Global Guide to Radio-Frequency (RF) Equipment Regulation: Your Comprehensive Guide for Ensuring Connected Devices Comply in the Age of the Internet of Things (IoT)
Second Edition © 2018, All Rights Reserved The CommLaw Group ▪ www.commlawgroup.com
This Guide reflects the state of applicable laws, rules and regulations as of 2018.
No part of the material contained herein may be reproduced by any mechanical, photographic, or electronic process, or in the form of a photographic recording, nor may it be stored in a retrieval system, transmitted or otherwise copied for private, public or commercial use, reposted, disclosed, or redistributed, without prior written permission from the copyright holders.
LEGAL NOTICE
This Guide has been prepared for informational purposes only and is not for the purpose of providing legal advice. Your use of this Manual does not create an attorney-client relationship between Marashlian & Donahue, PLLC and you. You should not act upon the information set forth herein without seeking professional counsel. The information in the Guide is not guaranteed or promised to be current.
Federal, State, and International laws and regulations governing communications are subject to change through legislation, court decisions, and regulatory decisions, policy shifts and rulemakings. Many such changes are often subject to adequate advance public notice before taking effect allowing time to adjust to any new requirements. However, recently, some changes are being effected with little or no advance notice. Before any major initiatives are undertaken the most prudent practice is to check on the current status of any applicable laws and regulations that may apply. Some of the content on this document may be considered Attorney Advertising under the applicable rules of certain states. Prior results do not guarantee a similar outcome.
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Table of Contents
Table of Contents ...... 2 INTRODUCTION ...... 6 17 'INTERNET OF THINGS' FACTS EVERYONE SHOULD READ...... 9 COUNTRY-SPECIFIC RF EQUIPMENT REGULATORY REQUIREMENTS ...... 13 UNITED STATES ...... 13 FCC Requirements and Equipment Classification ...... 13 E-Labeling ...... 18 Specific Absorption Rate Restrictions...... 19 Hearing Aid Compatibility Requirements ...... 19 Confidentiality ...... 20 Responsible Parties ...... 21 Equipment Modification ...... 22 Post-Market Surveillance ...... 22 FCC Enforcement Proceedings ...... 23 AUSTRALIA ...... 25 RF Equipment Laws/Regulatory Agencies ...... 25 Responsible Parties ...... 25 Regulated RF Equipment Types ...... 25 Compliance Standards and Authorization Procedures ...... 26 Labeling Requirements...... 27 Record Keeping ...... 28 Confidentiality ...... 28 Device Modification ...... 28 Market Surveillance ...... 29 Penalties for Non-Compliance ...... 29 BRAZIL...... 30 RF Equipment Regulatory Agencies ...... 30 ANATEL: TELECOMMUNICATIONS RADIOFREQUENCY DEVICES ...... 30 Telecommunications RF Equipment Laws/Regulations ...... 30 Responsible Parties ...... 30 Regulated RF Equipment Types...... 30 Authorization and Testing Procedures ...... 31 Application Fees ...... 33 Certification Application Processing Time ...... 33 Labeling Requirements ...... 33 Confidentiality ...... 34 Modifications to RF Equipment ...... 34 Market Surveillance ...... 34 Penalties for Non-Compliance ...... 35 INMETRO: INFORMATION TECHNOLOGY AND NON-TELECOMMUNICATIONS RADIOFREQUENCY DEVICES ...... 36 Responsible Parties ...... 36 Regulated RF Equipment Types...... 36
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Testing and Authorization Procedures ...... 36 Mutual Recognition Arrangements ...... 38 Application Fees ...... 38 Certification Application Processing Time ...... 38 Labeling Requirements ...... 38 Confidentiality ...... 39 Modifications to RF Equipment ...... 39 Market Surveillance ...... 39 Penalties for Non-Compliance ...... 40 CANADA ...... 41 RF Equipment Laws/Regulatory Agency ...... 41 Responsible Parties ...... 41 Testing and Authorization Procedures ...... 42 Application Fees ...... 44 Labeling Requirements...... 44 Confidentiality ...... 46 Modifications to RF Equipment ...... 46 Market Surveillance ...... 47 Penalties for Non-Compliance ...... 48 CHINA (PEOPLE’S REPUBLIC OF CHINA) ...... 49 RF Equipment Laws/Regulatory Agencies ...... 49 Responsible Parties ...... 49 Regulated RF Equipment Types ...... 50 Testing and Authorization Procedures ...... 50 Labeling Requirements...... 56 Confidentiality ...... 57 Modifications to RF Equipment ...... 57 Market Surveillance ...... 57 Penalties for Non-Compliance ...... 58 EUROPEAN UNION ...... 59 RF Laws/Regulations & Regulatory Agencies ...... 59 Responsible Parties ...... 59 Testing and Authorization Procedures ...... 61 Fees ...... 62 Declaration of Conformity ...... 62 Exceptions to Authorization Requirements ...... 63 Labeling ...... 63 Market Surveillance ...... 64 Confidentiality ...... 64 Penalties for Non-Compliance ...... 64 EU Privacy Regulations ...... 64 INDIA ...... 67 Responsible Parties ...... 67 Regulated RF Equipment Types ...... 67 Licenses, Testing and Authorization Procedures ...... 68 BIS Labeling Requirements ...... 73 Modifications of RF Equipment ...... 74 -3-
Enforcement ...... 74 JAPAN ...... 75 RF Equipment Laws/Regulatory Agencies ...... 75 Responsible Parties ...... 75 Regulated RF Equipment Types ...... 76 Testing and Authorization Procedures ...... 77 Application Fees ...... 80 Certification Application Approval Time ...... 80 Labeling Requirements...... 81 Confidentiality Procedures ...... 83 Modifications of RF Equipment ...... 83 Market Surveillance ...... 84 Penalties for Non-Compliance ...... 85 Mutual Recognition Agreements ...... 86 NEW ZEALAND ...... 87 RF Equipment Laws/Regulatory Agency ...... 87 Responsible Parties ...... 87 Equipment Subject to Laws/Regulations ...... 87 Authorization Procedures ...... 90 Labeling Requirements...... 91 Fees ...... 92 Exception to Authorization Requirements...... 92 Confidentiality Procedures ...... 92 Penalties for Non-Compliance ...... 93 RUSSIA ...... 94 RF Equipment Laws ...... 94 Regulated RF Equipment Types ...... 94 Regulatory Agencies ...... 94 Responsible Parties ...... 95 Testing and Authorization Procedures ...... 96 Application Fees ...... 97 Labeling Requirements...... 97 Confidentiality ...... 98 Modifications to RF Equipment ...... 98 Market Surveillance ...... 98 Penalties for Non-Compliance ...... 98 SOUTH AFRICA ...... 99 RF Equipment Laws/Regulatory Agency ...... 99 Responsible Parties ...... 99 Regulated RF Equipment Types ...... 100 Testing and Authorization Procedures ...... 100 Application Fees ...... 102 Certification Application Processing Time ...... 102 Labeling Requirements...... 102 Confidentiality ...... 103 Modifications to RF Equipment ...... 104 Market Surveillance ...... 104 -4-
Penalties for Non-Compliance ...... 105 SOUTH KOREA ...... 105 RF Equipment Laws/Regulatory Agencies ...... 105 Responsible Parties ...... 105 Regulated RF Equipment Types ...... 105 Testing and Authorization Procedures ...... 106 Application Fees ...... 112 Certification Application Processing Time ...... 112 Labeling Requirements...... 113 Confidentiality ...... 113 Modifications to RF Equipment ...... 113 Market Surveillance ...... 113 Penalties for Non-Compliance ...... 113 TAIWAN (REPUBLIC OF CHINA) ...... 114 RF Equipment Laws/Regulatory Agency ...... 114 Responsible Parties ...... 114 Regulated RF Equipment Types ...... 114 Testing and Authorization Procedures ...... 115 Application Fees ...... 116 Labeling Requirements...... 116 Modifications of RF Equipment ...... 117 Market Surveillance ...... 117 Penalties for Non-Compliance ...... 117 CONCLUSION ...... 118
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INTRODUCTION
Businesses of all kinds are rapidly realizing that new value is to be had by connecting traditional products to the Internet. The Internet of Things (“IoT”) (i.e., physical devices that can connect to the Internet wirelessly) is everywhere — in cars, in household appliances, even our bodies. We are in the midst of new developments that offer tremendous market potential. The Federal Trade Commission (“FTC”) estimates that by 2020 more than 50 billion connected devices will be part of the IoT.
The exponential growth of IoT is the result of manufacturers adding wireless modules into all manner of products, which subjects those products to radiofrequency (“RF”) equipment regulation by countries all over the world. In all nations, regulatory authorities can, and often do, impose significant penalties on manufacturers, importers, and other responsible parties that supply non-compliant RF products to the market. Ignorance of the regulations is no excuse.
Accordingly, we have prepared this Guide, which provides high-level regulatory overviews of RF equipment regulations and compliance requirements in many parts of the world. The current Guide summarizes RF equipment regulatory requirements in: the United States, Australia, Brazil, Canada, China, the European Union (Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and the UK), India, Japan, New Zealand, Russia, South Africa, South Korea, and Taiwan.
Virtually all devices that radiate RF energy and are manufactured, imported, and/or marketed in the subject nations are subject to stringent rules. The country summaries in this Guide provide valuable information concerning the pertinent RF equipment regulations in each country (or, in the case of the European Union, region). But, the country-specific rules are varied and complex. Accordingly, this Guide is for informational purposes only and does not constitute legal advice.1
1 This is not intended to create an attorney-client relationship between and you and Marashlian & Donahue, PLLC. Do not rely on the information provided in this Guide to determine your legal rights and obligations. -6-
The crux of all RF equipment rules is to ensure that proper safeguards are in place to prevent RF devices from causing harmful interference to other devices and communications operations in general. As such, each nation enforces rules to ensure that RF devices are properly tested for conformity with the applicable technical standards, authorized, and labeled before they are imported or marketed therein.
Failure to comply with the applicable regulations could result in substantial fines, equipment confiscation, and even in some cases, the banning of a company’s products from the market. Therefore, all potentially responsible parties should ensure that their equipment is in compliance with the applicable regulations at all times.
The information in this Guide will help the responsible parties understand and comply with applicable regulations. But, the compliance process itself is quite complex and time-consuming. Accordingly, enlisting the services of an experienced and efficient legal counsel or consultant for support through the necessary regulatory procedures is highly recommended.
This Guide is current as of the date of publication. Because all the rules described herein are subject to change, we advise regular review of the respective regulatory agency’s rules and updates. Subsequent editions of this Guide will include regulatory updates in the subject countries, and include additional country summaries.
About The CommLaw Group
The CommLaw Group is unique among its peers, offering clients a scope of capabilities rarely found in boutique law firms. With a headcount rivaling the Telecom Practice Groups of most major law firms, we boast a team of attorneys, paraprofessionals and consultants possessing the skills, focus, and resources necessary to serve the communications law needs of Fortune 100 companies, all without sacrificing the range of services and affordability which makes us the “go-to” firm for new entrants and service providers of all sizes.
In association with The Commpliance Group, which specializes in fixed-fee licensing and compliance services tailored to the communications industry, The CommLaw Group offers businesses the “Full Spectrum” of legal, regulatory, administrative, and consultative services.
You should seek the advice of a qualified attorney before attempting to market RF devices internationally or if you have any questions or concerns about your rights and compliance obligations. -7-
The CommLaw Group was recently profiled in The Wall Street Journal as one of the Capital Region’s Premier Law Firms.
Contact Us for Assistance
If you would like additional information concerning RF equipment regulatory issues or are interested in a legal consultation with Marashlian & Donahue, please feel free to call us at (703) 714-1305 or email Ronald E. Quirk, Jr. at [email protected] or Alexander I. Schneider at [email protected]. Consultation with knowledgeable counsel and/or consultants would be helpful to any company looking to avail itself of the opportunities in this marketplace. Successful ventures depend not only on solid business planning, but also proactive regulatory compliance to avoid being caught in the crosshairs of a regulatory enforcement body.
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17 'INTERNET OF THINGS' FACTS EVERYONE SHOULD READ
By: Bernard Marr
The Internet of Things is here and it’s growing rapidly. Internet of Things (IoT) or Internet of Everything (IoE) refers to devices or objects that are connected to the Internet, like your smartwatch, Fitbit, or even your refrigerator. These devices are able to collect and transmit data via the Internet, contributing to our big data world.
Smart, connected devices are already transforming our world and the competitive forces in business. To demonstrate how fast this sector is growing and what an impact it will have on our lives and business, I’ve rounded up 17 of the most mind-boggling IoT numbers and stats that prove that the phenomenon is here and here to stay.
1. The majority of people (87%) have not heard of the term ‘Internet of Things’. 2. ATMs are considered some of the first IoT objects, and went online as far back as 1974. 3. Back in 2008, there were already more objects connected to the Internet than people. 4. This year, we will have 4.9 billion connected things. 5. And some predict that by 2020, the number of Internet-connected things will reach or even exceed 50 billion. 6. In 2015, over 1.4 billion smart phones will be shipped and by 2020 we will have a staggering 6.1 billion smartphone users. 7. The IoT will connect many of the devices we have in our homes, from smart thermostats to smart fridges. Companies like Google and Samsung understand this. Google bought smart thermostat maker, Nest Labs, for $3.2 billion, and Samsung purchased connected home company SmartThings for $200 million. 8. By 2020, a quarter of a billion vehicles will be connected to the Internet, giving us completely new possibilities for in-vehicle services and automated driving. 9. In fact, we already have cars that can drive on their own – Google’s self-driving cars currently average about 10,000 autonomous miles per week. 10. The global market for wearable devices has grown 223% in 2015, with Fitbit shipping 4.4 million devices and Apple selling 3.6 million Apple Watches. 11. And yes, Internet-connected clothing is coming. Estimates predict that 10.2 million units of smart clothing will ship by 2020, compared to a meager 140K units in 2013. 12. Today, the market for Radio Frequency Identification (RFID) tags, used for transmitting data to identify and track objects, is worth $11.1 billion. This is predicted to rise to $21.9 billion in 2020. 13. Machine-to-machine (M2M) connections will grow from 5 billion at the beginning of this year to 27 billion by 2024, with China taking a 21% share and the U.S. 20%. 14. GE believes that the “Industrial Internet” (their term for IoT) will add $10 to $15 trillion to global GDP in the next 20 years. 15. According to estimations by the McKinsey Global Institute, the IoT will have a total economic impact of up to $11 trillion by 2025.
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16. Having a connected kitchen could save the food and beverage industry as much as 15% annually. 17. CISCO believes the IoT could generate $4.6 trillion over the next ten years for the public sector, and $14.4 trillion for the private sector.
The IoT is only going to grow. I believe that currently less than 0.1% of all the devices that could be connected to the Internet, are connected to the Internet. Just think of the tremendous potential and limitless opportunities this brings for business and society.
Bernard Marr is a best-selling author, keynote speaker and business consultant in big data, analytics and enterprise performance. The CommLaw Group Wants You to Read a Few More Facts About the ‘Internet Of Things’…
18. Virtually every single IoT device that connects to the Internet (“Connected Device”) is a device that emits “Radio-Frequency” (RF) energy. 19. All RF-emitting Connected Devices are subject to diverse and stringent Regulatory Requirements, not just here in the United States, but around the globe. 20. The Rules, Regulations and Governmental policies governing the licensing, authorization, import/export, and marketing of RF-emitting Connected Devices are complex and the consequences of non-compliance are severe.
The CommLaw Group’s Global Guide to Radio-Frequency (RF) Equipment Regulation should be every IoT company’s first stop to ensure the Connected Devices they manufacture, market and sell are in compliance with the U.S. and international rules, regulations and policies associated with their products and services.
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ABOUT THE AUTHORS
Ronald E. Quirk, Jr., Senior Managing Attorney at Marashlian & Donahue, PLLC, The CommLaw Group, focuses his practice primarily on federal, state, and international telecommunications regulation and policy, with a particular expertise in assisting clients navigate the complex labyrinths of radiofrequency (“RF”) equipment authorization and enforcement processes around the world. Mr. Quirk brings extensive legal experience to his current client representation. His career spans more than 20 years, including several years at AMLAW 100 firms and the Federal Communications Commission (“FCC”). He has successfully represented clients ranging from solo proprietorships to Fortune 500 corporations, in matters before the FCC, Department of Justice (“DoJ”), Department of Transportation (“DoT”), Food and Drug Administration (“FDA”), state public utility commissions (“PUCs”), international regulatory entities, and state and federal courts.
Alexander I. Schneider is an Associate Attorney at Marashlian & Donahue, PLLC, The CommLaw Group, specializing in regulatory law analysis and compliance. Mr. Schneider’s practice focuses on assisting The CommLaw Group’s wide range of communications clients with compliance with laws and regulations related to the introduction of new products and services, ongoing compliance, and corporate transactions. Specific matters include information privacy and data protection, telecommunications regulation, universal service compliance, audits and investigations, corporate transactions, and e-commerce. Mr. Schneider is a Certified Information Privacy Professional/United States (CIPP/US).
Marashlian & Donahue, PLLC, The CommLaw Group, is not your ordinary law firm. Together with The Commpliance Group, its affiliated consultancy, The CommLaw Group is a professional services “organization” that was specially designed and staffed to service the full-range of legal, consulting and compliance needs of the telecommunications, broadcast, information technology and Internet services and manufacturing industries. Boasting a vibrant and diverse communications law practice, The CommLaw Group currently serves hundreds of clients throughout the U.S. and internationally. The firm’s loyal base includes clients of all shapes and sizes, from start-ups to Fortune 100 enterprises, and from practically every sector of the communications and info tech industries. The firm also serves the intellectual property, privacy, cyber-security, litigation and general business law needs of its clientele.
In 2005, anticipating the seismic shift in the market for effective, yet affordable legal services, The CommLaw Group set out to engineer its one-of-a-kind, “Full Spectrum” professional services business model. The ground-breaking processes developed by the firm enable it to provide value-driven, high- quality professional services that deliver business-savvy solutions for reasonable, predictable, task appropriate costs; all provided with the customer-friendly approach that has become the firms’ hallmark characteristic.
The CommLaw Group is led by its founder and managing partner, Jonathan S. Marashlian, an AV Preeminent Rated, nationally-recognized expert in the areas of communications taxes, regulatory fees, regulatory litigation, audits, advocacy and defense. Winner of a SmartCEO Executive Management Award for his innovation and leadership in the legal profession, Mr. Marashlian also earned multiple Client Choice Awards by Lexology/International Law Office; named overall winner in the Telecommunications Law – USA category.
The CommLaw Group is the recipient of several ACQ Law and ACQ Global Awards and was named “Customer Service Law Firm of the Year” and “Best Communications Law Firm of the Year” in the U.S., and was profiled in the Wall Street Journal as one of Washington D.C.’s Premier Law Firms.
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Contact The CommLaw Group:
MARASHLIAN & DONAHUE, PLLC The CommLaw Group 1420 Spring Hill Road, Suite 401 McLean, Virginia 22102 Office Tel: 703-714-1313 Office Fax: 703-563-6222 E-Mail: [email protected] Website: www.CommLawGroup.com
ATTORNEY ADVERTISING DISCLAIMER: This information may be considered advertising in some jurisdictions under the applicable law and ethical rules. The determination of the need for legal services and the choice of a lawyer are extremely important decisions and should not be based solely upon advertisements or self-proclaimed expertise. No representation is made that the quality of the legal services to be performed is greater than the quality of legal services performed by other lawyers.
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COUNTRY-SPECIFIC RF EQUIPMENT REGULATORY REQUIREMENTS UNITED STATES
This section delineates the Federal Communications Commission’s (“FCC” or “Commission”) rules for the authorization and marketing of radiofrequency (“RF”) equipment. The FCC has very strict and specific rules to ensure that RF devices are properly tested for conformity with the Commission’s technical requirements, then authorized and labeled before they are marketed in the U.S.2 FCC WARNS: COMPLY BEFORE YOU MARKET!
The FCC has a very broad and comprehensive definition of “marketing” RF devices, including: “Sale or lease, or offering for sale or lease, including advertising for sale or lease,3 or importation, shipment, or distribution for the purpose of selling or leasing or offering for sale or lease.”4 Strict compliance with the FCC’s regulations is essential before marketing of RF devices may commence. The FCC has, and will continue to, impose substantial fines and other sanctions on entities that market or operate RF devices in violation of the federal Communications Act and/or Commission rules. There is a base sanction of $10,000 for willful violation of the Communications Act,5 as well as a $500 per day fine for willful violation of FCC rules.6 Each non-compliant RF device that is marketed constitutes a separate violation.7
In recent years, the FCC has not been reticent about levying large financial sanctions on companies that market non-compliant RF devices; some of which have totaled in the hundreds of thousands of dollars.8 The FCC has also been actively using its authority to order unauthorized or illegal RF devices off the market.9 Accordingly, it is critical that all responsible parties (as defined below) have a solid understanding of the FCC’s rules and ensure compliance with them before introducing their RF devices to the U.S. market. FCC Requirements and Equipment Classification
The testing and authorization requirements respecting RF devices vary considerably, depending on the FCC’s regulatory classification of a given device. The more interference potential a device has, the more stringent the authorization requirements.
2 See 47 U.S.C. §302(b). 3 “Advertising” includes traditional media advertising and other types of communications; even extending to a mere mention of the availability of a device on a company’s website. 4 47 C.F.R §2.803(a). 5 47 U.S.C. §302(b). 6 47 U.S.C. §501. 7 See 47 U.S.C. §502. 8 See e.g., ABC Fulfillment Services LLC et al., 32 FCC Rcd. 7300 (2017); ASUSTEK Computer, Inc., 29 FCC Rcd. 9974 (2014); Pilot Travel Centers, LLC, 19 FCC Rcd. 23113 (2004). 9 See e.g., Phong Le Company, 28 FCC Rcd. 08188 (2013). -13-
The FCC’s rules include four general categories of regulated RF equipment, each with specific and unique interference prevention and regulatory approval requirements: (1) incidental radiators; (2) unintentional radiators; (3) intentional radiators; and (4) telephone terminal equipment (“TTE”).10
Incidental Radiators and Interference Safeguards
An incidental radiator is a device that generates some RF energy during its operation, but does not transmit or utilize RF energy for any purpose. 11 Incidental radiators include equipment such as mechanical light switches and DC current motors. These devices are very lightly regulated. The FCC requires only that manufacturers of incidental radiators employ “good engineering practices” to diminish the risk of harmful interference before marketing.12
Unintentional Radiators and Authorization Requirements
An unintentional radiator is a device that generates RF energy for use within the device or that sends RF signals by conduction to associated equipment via wiring, but does not transmit RF energy for any purpose.13 In general, any RF device (except an incidental radiator) that does not transmit RF energy is classified as an unintentional radiator.14 Examples of unintentional radiators include TV and radio receivers, personal computers and peripherals, central processing unit (“CPU”) boards and power supplies, radio interface devices, battery chargers, radar detectors, as well as virtually any RF device containing a secure digital (“SD”) card that does not contain a transmitter.15
Unintentional radiators that use digital techniques are subdivided into two categories:
Class A Digital Devices - RF devices marketed for use in business and industrial environments.16
Class B Digital Devices – RF devices marketed for use in residential environments.17
The FCC does not permit Class A Digital Devices to be marketed to the general public in any fashion.18 Because Class B Digital Devices are intended to be sold to the public, they are subject to more stringent RF interference protection standards than are Class A Digital Devices.19 Accordingly, if a digital device is going to be marketed to the public, the responsible party should ensure that it is clearly categorized as Class B Digital Device when submitting the device to a laboratory for compliance testing and authorization.
Most unintentional radiators only require a Supplier’s Declaration of Conformity (“SDoC”) in order to be marketed or sold in the US.20 The SDoC is a procedure wherein the responsible party confirms
10See 47 C.F.R. §§15.3(n),(o),(z), 68.102. 11 47 C.F.R. §15.3(n). 12 47 C.F.R. §15.13. 13 47 C.F.R. §15.3(z). 14 Id. 15 See 47 C.F.R. §15.101. 16 47 C.F.R. §15.3(h). 17 47 C.F.R. §15.3(i). 18 See 47 C.F.R. §15.3(h). 19 See e.g., 47 C.F.R. §15.109. 20 The FCC maintains a list of unintentional radiators that are subject to certification rather than an SDoC. See 47 C.F.R. §15.101(a). Examples of devices subject to certification rather than SDoC are scanning receivers, radar detectors, and Access Broadband over Power Line devices. The Verification and Declaration -14- that equipment complies with appropriate technical standards.21 (See section on Responsible Parties below).
The SDoC procedure is typically initiated by submitting a prototype and other required information to a testing lab, obtaining a certificate from the lab (assuming the device passes the required tests) and retaining the certificate and testing records in case the FCC conducts an audit. Testing labs typically charge $2,500 - $5,000 for product testing, and the turnaround time is usually two weeks or less. There is no need to submit any information to the FCC unless requested.22
All devices that are “identical” to the tested prototype fall within the SDoC as long as they continue to comply with the FCC’s rules when they are marketed or operated.23 Hence, it is critical that responsible parties have strict quality control procedures in place to ensure that all identical RF devices marketed after testing and authorization comply with the pertinent FCC rules. All devices subject to the SDoC must include a compliance statement in the product literature that identifies for consumers who is responsible for the device’s compliance with FCC regulations.24 Additionally, the device’s user manual or instructions must contain a warning to the user that unauthorized modifications could void the user’s authority to operate the device.25
Also, a label must be placed in a conspicuous location on the device and contain the following statement:
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.26
The labeling requirements extend to advertising. All advertisements for RF devices (no matter how authorized) must include proper labeling information.27 Labeling is critically important, because a violation of this requirement is often the first thing that is noticed by competitors, which, when brought to the FCC’s attention, will almost certainly trigger an enforcement action.
Companies with existing RF equipment in the marketplace may be complying with now outdated rules that reference verifications or declarations of conformity. These companies will be required to comply with the SDoC procedures by November 1, 2018.
Intentional Radiators and Authorization Requirements
The FCC defines an intentional radiator as a “device that intentionally generates and emits radiofrequency energy by radiation or induction.”28 Basically, any device that transmits RF energy is procedures, from before 2017, have been eliminated. See In Re Amendment of Parts 0, 1, 2,15, and 18 of the Commission’s Rules regarding Authorization of Radiofrequency Equipment, First Report and Order, 32 FCC Rcd. 8746 (rel. July 14, 2017). 21 See 47 C.F.R. §2.906. 22 See id. 23 The FCC defines the term “identical” to mean, “identical within the variation that can be expected to arise as a result of quantity production techniques.” 47 C.F.R. §2.908. 24 See 47 C.F.R. §2.1077. 25 47 C.F.R. §15.21. 26 47 C.F.R. §15.19(a)(3). 27 See 47 C.F.R. §2.803(a). 28 47 C.F.R. §15.3(o). -15- an intentional radiator.29 Examples include cell phones, walkie-talkies, wireless connections, Bluetooth connections, short range broadcast equipment, wireless key-access systems, CB radios, and high- power transmitters such as commercial mobile two-way radio transmitters.30
Intentional radiators are authorized by the Certification process.31 A Certification is issued by an FCC- authorized Telecommunications Certification Body (“TCB”) based on representations and test data submitted by the applicant.32 Any entity seeking to obtain Certification of an RF device must comply with the following procedures.
First, the responsible party must obtain an FCC Registration Number (“FRN”). An FRN, which is required of all entities that do business with the FCC, is available for free by registering via the FCC’s website.33
Second, an FCC Grantee Code must be procured. A Grantee Code is a three or five digit code used to designate the manufacturer or other responsible party (referred to as the “Grantee”) for Certified RF devices.34 A Grantee Code, which currently costs $70.00, may be obtained by an online application through the FCC’s website.35
Third, a permissible operating frequency for the device must be chosen. Because many frequencies have restrictions on their use, it is advisable to review the FCC’s Table of Frequencies to determine which would be the most desirable frequency or frequencies on which an intentional radiator can operate. 36
After choosing the appropriate frequency, a production-ready device should be sent to an FCC- accredited laboratory for testing to ensure compliance with the applicable FCC rules.37 The lab tests for compliance with FCC requirements concerning output power, harmonics, and RF emissions.38
After testing is complete, the test results and a Certification application are submitted to a TCB for review and determination as to whether Certification will be granted.39 The current Certification fee
29 Id. 30 Many types of low power, unlicensed RF devices are subject to the FCC’s Part 15 rule technical requirements. Low power industrial, scientific and medical equipment are subject to Part 18 technical requirements. Higher-powered, licensed devices are subject to the technical requirements in various other rule sections: (a) Part 22 (cellular and other commercial mobile radio services (“CMRS”)); (b) Part 24 (personal communication service (“PCS”));(c) Part 25 (satellite); Part 27 (miscellaneous wireless services); (d) Part 73 (broadcast); (d) Part 74 (broadcast translators and boosters); (e) Part 80 (VHF transceivers and maritime radio); (f) Part 84 (respiratory protective devices); (g) Part 87 (aviation devices); (h) Part 90 (private land mobile devices); (i) Part 95 (personal radio devices); (j) Part 97 (amateur radio services);and Part 101 (fixed microwave devices). 31 47 C.F.R. §2.907(a). 32 Id. 33 See https://www.fcc.gov/help/getting-fcc-registration-number-frn-universal-licensing-system-uls. 34 47 C.F.R. §2.926(c). 35 See 47 C.F.R. §1.1103. All FCC fees are subject to change periodically. 36 See generally 47 C.F.R. §2.106. 37 See 47 C.F.R. §§2.907(a), 2.911(d). 38 The testing and measurement requirements for low power, unlicensed devices are contained in Part 15 or Part 18, depending on the type of device. See 47 C.F.R. §2.1041. For licensed devices, the testing and measurement requirements are specified in §§ 2.1046-2.1057 of the FCC’s Rules. 39 See 47 C.F.R. §2.911; see also In the Matter of Amendment of Parts 0, 1, 2, and 15 of the Commission’s Rules regarding Authorization of Radiofrequency Equipment, Report and Order, 29 FCC Rcd 16335 (2014) (“RF Equipment Order”) at ¶ 9. -16- for a receiver device is $540.00; for all other applicable RF devices, the fee is $1,390 per device.40 For many RF devices, the following information must be provided with the application in the form of a Technical Report: manufacturer name & address, installation and operating instructions, block diagram, test results, FCC ID, and photos of the device and its components.41
Some types of intentional radiators, such as Software Defined Radios (“SDRs”), have additional Certification requirements. 42 For example, Certification applications for SDRs must contain a description of the device’s software and security information describing how the software will not be modified by anyone but the Grantee.43
Once the review process has been completed and, assuming that the application is complete and testing results are accurate, the TCB will issue a Grant of Certification within a short period of time. Like unintentional radiators, intentional radiators must be properly labelled and user instructions included prior to being marketed or offered for sale. The Part 15 label is the same as for a SDoC device.44 All product advertisements must contain proper labeling information. Certification attaches to all subsequent marketed devices that are identical to the sample tested and found in compliance with the FCC’s rules.45
Telephone Terminal Equipment and Authorization Requirements
TTE is RF equipment that is (a) connected to the Public Switched Telephone Network (“PSTN”) or (b) connected to wireline facilities used to provide private line services.46 Examples of TTE include telephones, computer modems, fax machines, automatic dialers, ADSL modems, automated teller machines, private branch exchanges (“PBXs”), and local area network (“LAN”) gateways. Although TE does not directly pertain to IoT, manufacturers and importers of wireless devices may also manufacturer or import TE. Accordingly, information regarding the regulation of TE is included in this Guide.
TTE is authorized by one of two methods: (1) Certification or (2) a supplier’s declaration of conformity (“SDoC”).47 The Certification process is complex; requiring not only testing for compliance with the applicable testing criteria, but is also subject to the FCC’s rules concerning the TCB program.48 Most responsible parties, therefore opt for the SDoC, which is similar to the DoC procedure described above (e.g., testing for technical compliance, “self-declaring” compliance with applicable rules), with some additional requirements.49
Administrative Counsel for Terminal Attachments
The FCC has outsourced much of its TTE compliance protocol to thee Administrative Council for Terminal Attachments (“ACTA”). Authorization procedures require TTE to meet ACTA-adopted technical criteria to prevent four types of harms: (1) electrical hazards to operating company
40 See 47 C.F.R. §1.1103. 41 See 47 C.F.R. §2.1033. 42 SDRs have transmitters that can change frequency ranger parameters, power, and modulation type by a change in the device’s software. 47 C.F.R. §2.1 43 See 47 C.F.R. §2.944. 44 See 47 C.F.R. §15.19(a). 45 47 C.F.R. §2.907(b). 46 See 47 C.F.R. §68.100. 47 See 47 C.F.R. §§68.102, 68.201. 48 See 47 C.F.R. §§68.160, 68.162. 49 See 47 C.F.R. §68.324. -17- personnel; (2) damage to network equipment; (3) malfunction of billing equipment; and (4) degradation of service to customers other than the TTE user and that person’s calling and called parties.50
Once a responsible party has demonstrated compliance with the ACTA criteria regarding a specific device (e.g., SDoC), it is required to apply to ACTA to have its TTE listed in the ACTA database of approved TTE. The ACTA database is accessed by the FCC. U.S. Customs & Border Protection, as well as the public to verify that TTE conforms to the applicable FCC rules and ACTA standards.
Composite Systems and Authorization Requirements
A composite system incorporates different RF devices contained either in a single enclosure or in separate enclosures connected by wire or cable.51 FCC rules state that a composite system with different RF devices subject to different technical standards and authorization procedures requires each individual RF device within the System to comply with its respective standard.52 For example, if a composite system contains an intentional radiator subject to Certification and an unintentional radiator subject to SDoC, when the intentional radiator is submitted to a TCB for Certification, the applicant must include information about the entire system and indicate that the pertinent components comply, or will comply with the SDoC requirements before the system is marketed. The applicant will need to demonstrate that none of the measured emissions of the composite system will exceed the highest level permitted for any individual component. 53 All the pertinent components may be submitted to a certified lab at the same time for purposes of SDoC and Certification testing, as applicable. E-Labeling
Certain RF devices are eligible to display required labels electronically rather than on labels affixed to the device.54 Eligible devices are those equipped with an integrated electronic display screen or those that can only operate in conjunction with a device that has an electronic display screen.
After unlocking the device and opening the “settings” menu, only two additional steps are allowed before a user is able to pull up the required labeling information (for a total of three steps).55
Devices must still be labeled either on the device or device packaging, with the FCC ID or other required information, for purposes of verifying compliance at importation, marketing, and sale. These labels can be removable.56 At the time of purchase, the user should be provided with instructions (either as a packaging insert or a link to a direct website with the information) that make clear how to open regulatory e-labels.57
50 See 47 C.F.R. §68.3 51 47 C.F.R. §15.31(k). 52 Id. 53 Id. 54 See 47 C.F.R. §2.935. E-Labeling applies to labels that are affixed to a device, not those inserted into instructions or product documentation. 55 See 47 C.F.R. §2.935(c). 56 See 47 C.F.R. §2.935(f). 57 See 47 C.F.R. §2.935(b). -18-
Specific Absorption Rate Restrictions
The FCC also has rules limiting the amount of RF radiation that may be emitted from portable transmitting devices (“PTDs”) operating in certain frequency bands.58 The RF radiation limits are based on the localized specific absorption rate (“SAR”) criteria set by the American National Standards Institute (“ANSI”).59
The FCC defines a PTD as a device that is designed to be used so that the radiating structure of the device is within 20 centimeters of the body of the user.60 The FCC requires that PTDs operating in the “higher frequency bands” such as the 3650 MHz and 4.9 GHz bands undergo routine environmental evaluations prior to equipment authorization, in order to confirm their compliance with the SAR limits.61 Such devices must contain a SAR-compliance certification when submitted for Certification.62 The SAR limits and evaluation requirements for PTDs are listed in the Commission’s rules.63
The FCC’s rules are somewhat ambiguous as to what specifically constitutes “higher frequency bands” (e.g., whether operation in bands lower than 3650 MHz would require a routine environmental evaluation). But, a reliable FCC source has indicated that it is recommended that all PTDs undergo the routine environmental evaluations. Hearing Aid Compatibility Requirements
The FCC has additional rules regarding hearing aid compatibility (“HAC”) intended to ensure that consumers with hearing loss are able to access wireless communications services through a wide selection of handsets without experiencing disabling RF interference.64 Specifically, manufacturers and telecommunications service providers are required to offer minimum numbers or percentages of handset models that meet technical standards for compatibility with hearing aids operating in both acoustic coupling and inductive coupling modes.65
The HAC rules apply to all wireless handsets that contain a built-in speaker and are typically designed to be held to the ear.66 The FCC provides an exemption for handsets that are not designed to typically be held to the ear in any ordinary use, but provide voice communications through a speakerphone, headphone, or other instrument that carries voice communications form the handset to the ear.67
The FCC has stipulated that the word “typically,” in the context of HAC, means any intended or anticipated ordinary use, and does not mean “usually” or “most often.” If a handset is configured so as to enable a user to hold it to the ear to receive voice communications in any ordinary anticipated
58 See 47 C.F.R. §2.1093(c)(1). 59 See 47 C.F.R. §2.1093(d). 60 See 47 C.F.R. §2.1093(b)(1). 61 See 47 C.F.R. §2.1093(c)(1); see also Facilitating Opportunities for Flexible, Efficient, and Reliable Spectrum Use Employing Cognitive Radio Technologies, Notice of Proposed Rulemaking and Order, 18 FCC Rcd 26859, ¶ 45 (2003). 62 See 47 C.F.R. §2.1093(c)(3). 63 See 47 C.F.R. §2.1093(d). 64 See 47 C.F.R. §20.19(a). 65 See 47 C.F.R. §20.19(b)-(d). 66 See Amendment of the Commission’s Rules Governing Hearing Aid-Compatible Mobile Handsets, Policy Statement and Second Report and Order and Further Notice of Proposed Rulemaking, 25 FCC Rcd 11167 ¶¶ 74-93 (2010). 67 Id. at ¶ 20. -19- application, it is a “handset” covered by the HAC rules, even if the manufacturer or service provider expects that most users will operate it with a headphone, speakerphone, or other mode.68
Exceptions for Pre-Authorized RF Devices
RF devices may be marketed prior to authorization under certain limited circumstances, including:
product development or market trials, provided that an experimental licenses is obtained from the FCC;69
pursuant to rule wavier;70
sales contracts with vendors on condition that delivery is contingent upon FCC authorization;71
advertisements at trade shows or exhibitions, as long as a conspicuous notice is displayed that the device has not been authorized by the FCC and may not be offered for sale until such authorization is obtained;72 or
evaluation kits offered for sale to product developers, software developers, and/or systems integrators – for evaluation purposes only (subject to other restrictions).73
Similar rules exist that permit limited operation of pre-authorized RF devices, including pursuant to experimental license, rule waiver, special temporary authority, and for purposes of compliance testing, and exhibitions at commercial, scientific, and medical locations, as long as applicable notices that the devices are not yet authorized by the FCC are displayed.74 Confidentiality
TCBs are required to submit all test results and related documentation in applications for Certification to the FCC’s Equipment Authorization System (“EAS”); a database that is accessible by the public.75 Most information submitted to the TCB as part of the Certification application (e.g., block diagrams, schematic designs, etc.) is not considered confidential.
If confidentiality for any information is desired, a request for same must be provided to the FCC at the time the application is submitted to the TCB. Explanations as to why release of the information would cause harm to the applicant (e.g., trade secrets) must be included in the confidentiality
68 Id. 69 47 C.F.R. §§2.803(c)(1), 5.601, 5.602. Experimental licensees may sell equipment to another licensee (manufacturer to licensed service provider) and lease equipment to trial participants for purposes of an experimental trial. The rule strictly limits the number of devices that may be marketed and also requires that all equipment must be retrieved or rendered inoperable after the trial. See 47 C.F.R. §5.602(d)(e). 70 47 C.F.R. §2.803(c)(2). 71 47 C.F.R. §2.803(c)(2)(i)(ii). 72 47 C.F.R. §2.803(c)(2)(iii). 73 47 C.F.R. §2.803(c)(2(iv). 74 See 47 C.F.R. §2.805(c),(d),(e). 75 See https://apps.fcc.gov/oetcf/eas/reports/GenericSearch.cfm. -20- request.76 The subject items must be labeled as “CONFIDENTIAL” in the filing and a $195.00 payment included.77
Note that items such as photos and test results are typically not eligible for confidential treatment. But, confidential treatment for these items can be requested, and may be granted if sufficient showing of competitive harm in the event of public disclosure is presented.78 Responsible Parties
The FCC has very specific rules as to who is responsible for regulatory compliance regarding various types of RF devices. As discussed below, different responsible party rules apply for RF devices subject to different types of authorization.
The responsible party is the exclusive party that is required to ensure that RF devices under its custody comply with FCC rules. This includes all identical devices marketed after authorization. Because the responsible party is liable for non-compliant RF devices and related matters, that party will be subject to FCC enforcement actions in the event potential rule violations are discovered.79
In the case of RF equipment subject to Certification, the responsible party is the party to whom the Certification Grant is issued (typically, but not always, the manufacturer or importer of the subject device).80 But, if an unauthorized party not affiliated with the Grantee modifies the equipment, that party becomes the responsible party for the particular device.81
For RF equipment subject to the SDoC procedure, the responsible party must be located in the US. The following are examples of responsible parties:
The manufacturer If the equipment is assembled from individual parts, then the assembler. If the equipment is imported, the importer. A retailer or original equipment manufacturer, if designated by contract. If modified by someone other than the responsible party, then the party performing the modifications.82
Regarding TTE, if a device is Certified, the responsible party is the holder of the Certification.83 For TTE that is subject to a SDoC, the responsible party is the device usually the manufacturer or importer.84 But, the responsible party could be another entity in the supply chain under certain circumstances. For example, the responsible party is the manufacturer who develops the protected circuitry that is marketed with the device if it is not connected to the network. If the TTE is assembled
76 47 C.F.R. §§0.457, 0.459. 77 Id.; 47 C.F.R. §1.1103. 78 See 47 C.F.R. §§0.457, 0.459. 79 See 47 C.F.R. §2.909. 80 47 C.F.R. §2.909(a). 81 Id. 82 See 47 C.F.R. §2.909. 83 See 47 C.F.R. §68.4. 84 Id. -21- from component parts, the responsible party is the assembler.85 Retailers of TTE may contract with the original responsible party to assume those duties.86
Additionally, any responsible party for TTE must obtain an ACTA Responsible Party Code (“RPC”) via ACTA’s website.87 The data associated with an RPC application (mainly responsible party contact information) must be updated on a yearly basis. The fee for an RPC is $825, and an RPC must be obtained before TTE authorization is registered on the ACTA website. The annual fee is $125; the fee is discounted to $95 if the application is filed early.88 Equipment Modification
Modifications to equipment subject to Certification that change the basic frequency determining and stabilizing circuitry, frequency multiplication stages, basic modulator circuit or maximum power or field strength ratings require a new certification.89
There are two pertinent classes of “permissive” modifications to Certified equipment that do not require re-certification.90 These modifications may typically only be made by the Grantee.91
A Class I permissive change is a modification that does not degrade the characteristics of the device as certified. No FCC filing is required for this type of modification.92
A Class II permissive change is a modification that degrades the certified characteristics of the device but the degraded performance of the device still meets the minimum requirements of the applicable technical rules. The responsible party (Grantee) must file test results and other information with the FCC showing complicity with the pertinent rules. The modified equipment cannot be marketed until the FCC grants approval of the modification.93
Regarding TTE, the FCC prohibits changes to the equipment or protective circuitry if it results in a material change to the information in the SDoC.94 Minor modifications to TTE may be done only by the original responsible party.95 Post-Market Surveillance
FCC rules require TCBs to conduct post-market surveillance of RF equipment they have Certified.96 The FCC can, and will, conduct post-market surveillance regarding equipment subject to SDoC.97 This surveillance is intended to ensure that marketed RF equipment conforms to the technical parameters
85 Id. 86 Id. 87 See http://www.part68.org/FAQ_datavalidation.aspx. 88 Id. 89 47 C.F.R. §2.1043(a). 90 47 C.F.R. §2.1043(b). There is a third category of permissive change that applies to SDRs only. 91 47 C.F.R. §2.1043(b(4). 92 47 C.F.R. §2.1043(b)(1). 93 47 C.F.R. §2.1043(b)(2). 94 See 47 C.F.R. §68.348(a). 95 See 47 C.F.R. §68.348(b). 96 47 C.F.R. §§2.945(b), 2.962(g). 97 47 C.F.R. §2.945(b). -22- of the equipment that was tested and authorized.98 TCBs and the FCC conduct surveillance by obtaining sample RF devices on the market, measuring the characteristics, and comparing them to the characteristics of the prototypes that were authorized.99
A TCB is required to conduct surveillance at a rate of at least five percent of all its certified RF devices.100 Responsible parties whose RF devices are under surveillance must, upon request, provide the investigating TCB with a sample RF device or vouchers to purchase any sample device it wishes in order to conduct the surveillance.101 And, if special software or specialized mechanisms are required to test marketed devices, the responsible party must provide them to the TCB at no charge.102
If a TCB or the FCC determines that a sample RF device is non-compliant (which typically occurs when manufacturers or marketers use replacement parts or otherwise modify the RF equipment from what was certified), the TCB will (as applicable) immediately inform the FCC and the responsible party; the FCC will likewise notify the responsible party as applicable.103 The responsible party will have 30 days to inform the TCB in detail as to how it will resolve the non-compliance issue.104 If the TCB is not satisfied with the information provided, the FCC will conduct arbitration between the TCB and the responsible party to resolve the matter.105 FCC Enforcement Proceedings
The FCC will commence an enforcement proceeding if it suspects that a non-compliant RF device is being marketed or operated in violation of its rules. The FCC typically discovers potential rule violations when a competitor or customer files a complaint involving an RF device or through post-market surveillance. As previously discussed, violations of the Communications Act or Commission rules could result in the responsible party being subject to steep monetary fines and removal of equipment from the marketplace.106
Enforcement proceedings are prosecuted by the FCC’s Enforcement Bureau (“Bureau”). When a complaint is filed or a potential violation is otherwise discovered, the Bureau will conduct a field investigation (often involving reviewing the target company’s website and other advertising) to gather more evidence. At the completion of the field investigation, the Bureau will serve a Letter of Inquiry (“LOI”) on the responsible party.
A LOI typically contains a summary of the complaint/investigation, including the rules alleged to have been violated. The LOI requires the recipient to answer questions and produce documents relevant to evaluating whether a violation has occurred, and if so, the nature and scope. A response is required, typically within 30 days of the date the LOI was served. The responsible party must provide the information requested by the Bureau, but it also has the option to request a meeting with the Bureau to explain factual and legal matters, and/or provide such information in its response.
Depending on the information contained in the response to the LOI, the Bureau may request additional information, cease prosecution, or issue a Notice of Apparent Liability for Forfeiture (“NAL”), describing
98 See RF Equipment Order at ¶ 24. 99 47 C.F.R. §2.945(b). 100 See RF Equipment Order at ¶ 25. 101 Id. 102 See RF Equipment Order at ¶ 27. 103 Id. at ¶¶ 24-25. 104 47 C.F.R. §2.962(g)(5). 105 See RF Equipment Order at ¶ 24. 106 See supra nn. 4-9 and accompanying text. -23- the case against the responsible party and listing any preliminary monetary forfeitures and/or other sanctions levied against the responsible party. The responsible party may file a response to the NAL, disputing the charges and seeking reduction of the proposed sanctions.
The Bureau will consider the response to the NAL and then will issue a Liability Notice, listing the “final” amount of the fine and any other sanctions imposed on the party, and ordering compliance with same.
A targeted party could also choose to resolve the matter by negotiating a consent decree with the Bureau. Consent decrees typically result in the responsible party admitting liability, agreeing to pay a (somewhat reduced) fine, implementing compliance procedures to ensure the violation does not occur in the future, and submitting periodic progress reports to the Bureau. The Bureau does not always agree to negotiate consent decrees, and even if it does, negotiating favorable terms can be difficult. Nonetheless, if the initial sanctions contain a requirement to pull RF devices from commerce, a consent decree, if properly negotiated, will nearly always result in exempting a party from having to take its devices off the market.
The initial LOI phase of an enforcement proceeding is private, but NALs, Liability Notices, and consent decrees are released to the public.
-24-
AUSTRALIA
RF Equipment Laws/Regulatory Agencies
The Radiocommunications Act 1992 (“Act”),107 empowers the Australian Communications and Media Authority (“ACMA”) to regulate radiofrequency (“RF”) devices for sale, marketing, and importation in the country.108 The Electrical Regulatory Authorities Council (“ERAC”) is an independent organization that oversees a national database through which parties responsible for RF equipment compliance must register.109 Responsible Parties
RF equipment “suppliers” are responsible for ensuring that their devices meet the applicable technical standards, authorization, labeling, and record keeping requirements before the devices may be marketed or imported into Australia. Suppliers include Australian manufacturers, as well as importers from any country or authorized agents acting on their behalf.110
First-time suppliers are required to register on the ERAC national database.111 Registration requires an Australian Business Number (“ABN”), and suppliers are required to provide technical information about the RF devices they market in Australia.112 Registration must be renewed annually; the fee for the annual renewal is $200.113 Regulated RF Equipment Types
All RF devices that fall within the scope of an ACMA standard must be properly authorized.114 ACMA’s Product Family and Equipment Standards List (“List”) cross-references RF device categories with their applicable standards.115 Almost all types of RF devices are contained in the List.116 But, if none of the listed standards apply to a specific device, then an ACMA generic standard becomes the default standard for that device.117 The ACMA requirements concern RF emissions limits only (as opposed to
107 See Radiocommunications Act, No. 174, 1992, Compilation No. 60 (Registered Apr. 8, 2015). 108 Id. at §7. 109 See https://www.acma.gov.au/Industry/Suppliers/Product-supply-and-compliance/Steps-to- compliance/supplier-registration. 110 Id. 111 Id. 112 Id. If the equipment described is “In-Scope Electrical Equipment” - low voltage electrical equipment that is rated at greater than 50 V AC RMS or 120V ripple-free DC (extra-low voltage); and less than 1000V AC RMS or 1500V ripple-free DC (high voltage) – the supplier must ensure that it meets electrical equipment safety system (“EESS”) requirements. See www.erac.gov.au (“EESS Registration”). 113 See www.comtest.com.au/compliance/rcm-part-2-electrical-safety-erac-and-the-eess. Fees are subject to change. 114 For non-RF devices or devices with both RF and non-RF components, electromagnetic compatibility standards and labeling rules may also apply. See Radiocommunications Labelling (Electromagnetic Compatibility) Notice 2008, ACMA, F2013C00117 (Mar. 2013), https://www.legislation.gov.au/Details/F2013C00117. These separate rules may require testing and/or a declaration of conformity. 115 See https://www.acma.gov.au/Industry/Suppliers/Regulatory-arrangements/EMC-Electromagnetic- compatibility/emc-standards-list (“List”). 116 Id. at 2-16. 117 Id at 1. -25- other countries’ regulations that address technical standards beyond RF emissions). Accordingly, although the ACMA standards cover a wide range of technical matters, authorization of RF equipment in Australia requires compliance solely with the RF emissions sections of those standards.118
ACMA categorizes RF devices according to their interference potential:
Low-risk devices have a low interference potential, even if operated in contravention of the applicable standard. Examples include remote control models, wireless microphones, and garage door openers.
Medium-risk devices are those that may have some risk of interference if operated outside of the applicable standard. Examples include televisions, laptops, PCs, video game consoles, stereo equipment, DVD players/recorders, mobile phone chargers, and printers.
High-risk devices have a high interference potential if operated in violation of their standards. These are devices that intentionally transmit RF energy, including microwave ovens, many types of telecommunications devices, induction heating equipment, and RF welding equipment.119 Compliance Standards and Authorization Procedures
After determining the risk level of its particular device(s), a supplier is required to review the applicable compliance levels, cross-reference the applicable ACMA compliance standards, ensure compliance with same and then conduct the appropriate authorization procedures.120
Compliance Level 1 (low-risk devices). Low risk devices must comply with the applicable standard, but no testing is required. For authorization purposes, supplier must prepare a detailed description of the device and complete a Supplier’s Declaration of Conformity (“SDoC”).121
o SDoC is accomplished by completing an ACMA form that requires a supplier’s contact information, product description, evidence of compliance (including test results, if applicable) and a signed declaration that the subject device complies with the applicable standard. For low-risk devices, the compliance evidence submitted is at the discretion of the supplier. SDoC is not submitted to any regulatory agency, but it must be retained by the supplier, and provided to ACMA upon request.122
Compliance Level 2 (generally medium-risk devices). Supplier must: (a) comply with the Compliance Level 1 requirements (including preparation of an SDoC); and (b) compile specific written evidence that the device complies with the applicable standard, which must contain one of the following:
118 Id. 119 See Radiocommunications (Compliance Labelling – Devices) Notice 2014, ACMA, F2017C01074 (Nov. 22, 2017) (“Compliance Labelling Notice”) at § 4, https://www.legislation.gov.au/Details/F2017C01074. 120 Id. at §12. 121 Id. at §13. 122 See ACMA Form 602 (Eff. Feb. 2015). -26-
o written authority from the U.S. FCC, demonstrating that the device is authorized to operate in the U.S., and information showing that it was altered to meet Australian requirements where they diverge from U.S. requirements;
o a test report from either an ACMA-accredited;
o a test report from a non-accredited testing body; or
o the manufacturer’s performance specifications for the device.123
Compliance Level 3 (generally high-risk devices). Supplier must: (a) meet the Compliance Level 1 requirements; and (b) compile evidence that the device conforms to the test results from an ACMA-accredited testing body, showing that the device complies with the applicable standards. The test report must include:
o description of tests used;
o results of the tests, including all testing data; and
o information concerning whether the results of the test show that the device conforms to the applicable standard.124 Labeling Requirements
Once an RF device has been authorized, it must be properly labeled before importation or marketing of the device may commence.125 For devices manufactured within Australia, the manufacturer or authorized agent is responsible for affixing the label to the device. For imported devices, the importer is responsible for labeling.126
ACMA has adopted a single compliance label - the Regulatory Compliance Mark (“RCM”):127
Suppliers are required to follow the applicable labeling rules:
Labels must be at least 3 mm high, permanent and durable and, if possible, placed on the surface of the device.
If a label cannot be placed on the surface of the device, it must be affixed to the external surface of the packaging, and included in the user manual or warranty/guarantee certificates. The label must be clearly visible and occupy an area greater than 1% of the
123 Compliance Labelling Notice at §14. 124 Id. at §§15-16. 125 Id. at §8. 126 Id. There are exceptions for devices installed in motor vehicles. 127 Id. at §9. For devices authorized before March 2016, certain alternative compliance marks are permitted. But, ACMA prefers the RCM, even for those devices, as the labelling process is being streamlined. See https://www.acma.gov.au/Industry/Suppliers/Product-supply-and-compliance/Steps-to- compliance/product-labelling. -27-
packaging surface. Also, the supplier must keep records of why a label cannot be applied to the device surface and where it is affixed.
Electronic labeling is permitted. If e-labeling is used, the supplier must ensure that instructions are placed in the user’s manual, explaining how to display the label.
Suppliers of wireless audio transmitters must, in addition to the RCM, label the device as follows: “This device operates under an ACMA class license and must comply with all the conditions of that license including operating frequencies. WARNING: After 31 December 2014, in order to comply, this device must not operate in the 694-820 MHz band.”128 Record Keeping
Suppliers of most types of RF equipment are required to keep records of their RF equipment authorization procedures for possible inspection by ACMA. The following records must be kept, when the subject device has been modified until five years after the device is no longer supplied in Australia:
DoC;
device description;
for high-risk devices, test report, and for variants, identification of the device and the variant, description of the device and variant, and explanation of how the variant device does not affect conformity with applicable standard;
for medium-risk devices, records of the reasonable written evidence, as described above; and
for devices that cannot accommodate a label (and for which the label is placed other than on the device), reasons why the label cannot be affixed to the device and where it is located.129 Confidentiality
All information, relating to RF equipment tested by ACMA is treated as “commercial in confidence,” and will not be disclosed to any third party without the written permission of the supplier of the equipment being assessed, unless otherwise required by law.130 Device Modification
If certain changes to a compliant model are made, the supplier must prepare a new DoC. The supplier, in addition to making the new declaration, must make a written and signed statement with the following information:
identifying the modified device;
identifying the modification; and
128 Id. at §9. 129 Id. at §§18-21. 130 See https://www.acma.gov.au/theACMA/devices-faq. -28-
describing the difference between the modified device and original device.
The supplier must ensure that the modified device is tested (if necessary) and meets the requirements of each applicable standard relevant to the modification at the appropriate compliance level, as well as keep a record of the results of each test carried out.131 Market Surveillance
ACMA routinely conducts audits on suppliers. ACMA determines its audit targets by a number of different methods:
random selection from the ERAC database;
receipt of written complaint;
devices identified at retail outlets;
devices identified in advertisements; and
interference issues.132
When a supplier is selected for audit, ACMA will provide written notice to the supplier at least 10 working days before the proposed date of the audit. The auditor will examine the documents that form the compliance records. If the auditor is satisfied that all the documentation and reports are correct, the supplier will be given an audit completion statement. If the auditor determines that a violation exists, it will commence an enforcement proceeding.133 Penalties for Non-Compliance
Penalties for non-compliance with Australia’s RF equipment regulations can be substantial. The penalties include fines and imprisonment depending on the type and severity of the offense:
Failing to retain records - 20 penalty units.134
Applying a label before meeting all the authorization requirements - 100 penalty units.135
Knowingly providing false or misleading information to the ACMA - 12 months imprisonment.136
The value of a penalty unit for calculating financial penalties is $170.
131 See Electromagnetic Compatibility, Compliance and Labeling Information for Suppliers of Electrical Electronic Devices, ACMA (July 2012) at 10-11. 132 Id. at 20. 133 Id. 134 Act at §§187, 315. 135 Id. 136 Criminal Code Act, §137.1. -29-
BRAZIL
RF Equipment Regulatory Agencies
Two government bodies oversee the Radiofrequency (“RF”) equipment regulatory process in Brazil. The Agência Nacional de Telecomunicações (“ANATEL”) supervises the RF equipment certification process for telecommunications RF equipment (“TRE” as described below).137 The National Institute of Metrology, Quality and Technology (“INMETRO”) has jurisdiction over general product safety standards, and is the agency that certifies information technology equipment (“ITE”), and various non-telecom RF-producing appliances.138 ANATEL: TELECOMMUNICATIONS RADIOFREQUENCY DEVICES
Telecommunications RF Equipment Laws/Regulations
The General Rule of Telecommunications (“Rule 9472”) established the national telecommunications regulatory framework in Brazil. 139 This law created ANATEL, which in addition to supervising telecommunications RF equipment certification, implements standards, conducts type approval (“homologation”), engages in market surveillance for regulatory compliance, and establishes authorized bodies for RF telecommunications equipment certification.140 Responsible Parties
Manufacturers and importers of telecommunications RF equipment with an in-country presence in the form of a locally registered company (either directly or via an authorized agent) are the parties responsible for ensuring compliance with ANATEL’s regulatory requirements.141 These responsible parties must ensure that their RF devices are properly tested to meet the applicable technical standards, and that they are certified and labeled prior to marketing or importing them in Brazil.142 Regulated RF Equipment Types
There are three categories of RF devices subject to the ANATEL certification processes:
Category I. This category consists mainly of end-user terminals intended for use by the general public. Examples include: wired/mobile satellite/VoIP phones, Internet modems, and fax machines.143
Category II. This category includes transmitting devices that do not fall within Category I. Examples include: television/radio transmitters, Wi-Fi equipment, and RF automation devices.144
137 General Rule of Telecommunications, Federal Law 9472/97 at Art. 8 (1997). 138 See Establishment of INMETRO, Federal Law 5966/73 at Art. 4 (1973). 139 See generally Rule 9472 (1997). 140 Id. at Art. 8. 141 ANATEL, Resolution No. 242 at Art. 28 (Nov. 30, 2000) (“Resolution No. 242”). 142 Id. at Art. 2. 143 Id. at Art. 3 (III). 144 Id. at Art. 3 (IV). -30-
Category III. This category includes products that are not classified as either Category I or II, but nevertheless require regulation in order to assure network capability and safety. Examples include: mobile network signal transmitters, cable connectors, and optical fiber cables.145 Authorization and Testing Procedures
Certification of RTE is performed by an Organismos de Certificação Designado (“OCD”), a third-party organization accredited by ANATEL that is responsible for the authorization of TRE.146 The testing and certification processes are as follows.
A responsible party must first register with ANATEL, and contact an OCD.147 The OCD is responsible for determining what information and documentation is required for the completion of the certification process.148
An OCD typically requires the following information for a certification application:
applicant/manufacturer name and contact information;
product samples;
user’s manual;
technical specifications;
internal/ external product photographs;
electrical schematics; and
ISO 9001 Certification of the manufacturing plant (for Category I products with multiple manufacturing plants).149
The required number of product samples varies greatly by product category.150 The application and product samples are pre-reviewed by ANATEL and the OCD, and will receive an initial certification by those organizations if they meet the required specifications.151 Once the product receives an initial certification, a suitable testing laboratory is chosen.152
TRE must undergo testing by an INMETRO-accredited testing lab, an OCD, or a foreign lab accredited by the International Laboratories Accreditation Cooperation (“ILACs”).153 ANATEL promulgates the specific testing requirements and technical specifications for each form of RF Equipment.154 Testing of RF Equipment devices generally covers the following areas: (1) electromagnetic compatibility
145 Id. at Art. 3 (V). 146 Resolution No. 242 at Art. 11. 147 See Certification and Homologation Process, ANATEL; see also Resolution No. 242 at Art. 20. 148 ANATEL, Resolution No. 323 at §§ 7.1.1-7.1.2, 7.3.1-7.3.2 (Nov. 7, 2002). 149 See, e.g., Required Documentation, MASTER Associação de Avaliação de Conformidade Telecom. 150 See, e.g., ANATEL, Resolution No. 442 at Art. 5 (July 7, 2006) (1 sample for EMC devices); ANATEL, Resolution No. 481 at Annex I (Sept. 10, 2007) (54 samples for Lithium batteries). 151 See Certification and Homologation Process, ANATEL. 152 Id. 153 ANATEL, Orientações Complementares para Seleção de Laboratórios de Ensaios para Fins de Certificação, Instrumento de Gestão, DOC.IG/01-v.05 (Dec. 17, 2004). 154 Resolution No. 242 at Art. V, VI; Resolution No. 323 at §7.2.1. -31-
(“EMC”); (2) safety; (3) RF emissions limits; and (4) for certain devices that are used close to the body, specific absorption rate (“SAR”).155 Devices must meet the standards of the Brazilian Conformity Assessment System (“SBAC”).156 After the lab completes testing, the results are forwarded to the OCD for review.157
The OCD reviews the application and test results, and will issue one of the following certifications depending on the product type:
Category I. Declaration of Conformity (“DoC”) with System Quality Evaluation;
Category II. DoC Based on Type Analysis and Periodic Evaluation of the Product; and
Category III. Certification of Conformity Based on Type Analysis.158
Once the OCD has certified the product, the applicant must register the product with the Serviço de Gestão de Certificação e Homologação (“SGCH”), a database of all products registered and certified in Brazil.159 The applicant will be required to pay for the registration via a Boleto Bancário, a Brazilian invoice payment system.160
Once the device has been certified and the applicant has completed product registration, the OCD will notify the applicant of the certification.161 ANATEL reviews the application, and issues a homologation certification (type approval) if the following additional documents are submitted by the applicant and deemed acceptable by ANATEL:
Homologation Requirement Form;
OCD certification;
product manual;
copy of the GS1 Brazil Letter of Registry; and
photograph of the ANATEL prototype identification stamp.162
155 See, e.g., Resolution No. 442 (EMC devices – reference to CISPR 22(2005), and IEC 61000-4-X); ANATEL, Resolution No. 529 (June 3, 2009) (product safety specifications – reference to IEC 60950 (2005)); ANATEL, Resolution No. 506 (July 1, 2008) (Wi-Fi and Bluetooth equipment are equivalent to FCC 15.247 (2003)). 156 The specific Brazilian standards are listed in various Resolutions: Resolution No. 442 – EMC (reference to CISPR 22 (2005)/IEC 61000-4-X); Resolution No. 529 – Safety (Reference to IEC 60950 (2005)); ANATEL, Resolution No. 506 (July 1, 2008) – RF Section IX – WiFi and Bluetooth are equivalent to the FCC regulations for same (2003); ANATEL, Resolution No. 533 (Sept. 10, 2009) – SAR; ANATEL, Resolution No. 481 (Sept. 10, 2007) – Lithium Batteries. 157 See Certification and Homologation Process, ANATEL; Resolution No. 323 at § 7.2.3. 158 See Certification and Homologation Process, ANATEL; Resolution No. 242 at Art. 21. 159 Serviço de Gestão de Certificação e Homologação (“SGCH”), ANATEL. 160 See id. 161 See Certification and Homologation Process, ANATEL; Resolution No. § 7.5.3. 162 Resolution No. 242 at Art. 29. -32-
Following certification, ANATEL will then issue the stamps required for product sale.163 Technically speaking, ANATEL homologation certifications never expire. However, OCD technical certificates must be periodically renewed as follows:
Category I Products – Must be renewed every year, and requires both product testing and factory evaluations;
Category II Products – Must be renewed every 2 years, and requires product testing; and
Category III Products – Renewal is only required if the product is modified, or if the applicable ANATEL technical standard is revised, and requires product testing.164 Application Fees
While other costs may be associated with the ANATEL certification process (i.e., OCD fees, testing laboratory fees, etc.), the applicant must pay ANATEL a Homologation fee of R$500.00 (USD $123.80). Renewal application fees are R$200.00 (USD $49.52).165 Certification Application Processing Time
The ANATEL homologation certification process can take anywhere from 1 to 4 months depending on the product type.166 Labeling Requirements
Products certified by ANATEL must comply with the Brazilian Consumer Protection Code of 1990 (CPC).167 The CPC requires that product labels provide consumers with accurate, comprehensible, precise, and easily readily information regarding the product’s origin, as well as technical and safety specifications.168
ANATEL requires that all labels are: (1) black and white (unless ANATEL provides prior authorization); (2) visible to the naked eye; (3) non-cell phone labels contain text at least 1 millimeters in size; and (4) placed on the product, or in user’s manual if insufficient space to do so.169 A typical label appears as follows:
163 See Certification and Homologation Process, ANATEL; Resolution No. 242 at Art. 39. 164 Resolution No. 242 at Art. 34. 165 ANATEL, Resolution No. 242 at Annex II. Fees are subject to change. 166 See An ANATEL Product Homologation, TechInBrazil (Aug. 24, 2014) at 3. 167 See generally Consumer Protection Code, Law No. 8.078 (Sept. 11, 1990). 168 Id. at Art. 31. 169 ANATEL, Resolution No. 242 at Annex III. -33-
RF Equipment devices subject to Resolution No. 506 technical specifications (e.g., Wi-Fi, Bluetooth) must also include the following statement on its product label:
Este equipamento opera em caráter secundário, isto é, não tem direito a proteção contra interferência prejudicial, mesmo de estações do mesmo tipo, e não pode causar interferência a sistemas operando em caráter primário.170
Also, RF Equipment devices tested for SAR must have the following statement present on its product label:
Este produto está homologado pela Anatel, de acordo com os procedimentos regulamentados pela Resolução nº 242/2000 e atende aos requisitos técnicos aplicados, incluindo os limites de exposição da Taxa de Absorção Específica referente a campos elétricos, magnéticos e eletromagnéticos de radiofreqüência, de acordo com as Resoluçãos nº 303/2002 e 533/2009. Confidentiality
ANATEL Resolution No. 242 requires the agency and OCDs to maintain the confidentiality of all technical or other information regarding products seeking ANATEL certification.171 Modifications to RF Equipment
Modifications that to certified devices that include alterations to the technical specifications may require the manufacturer to reapply for certification, depending on the degree of modification.172 Market Surveillance
ANATEL periodically performs market surveillance of products for compliance with ANATEL technical regulations, and labeling requirements.173 Violators are notified of their product’s non-compliance, and are required to remedy such violations.174 Violators that do not remedy their product’s regulatory violations may face penalties and other sanctions imposed by ANATEL.175
170 Resolution No. 506 at Art. 6. 171 Resolution No. 242 at Art. 2 (VII). 172 Id. at Art. 38. 173 Id. at Title VI. 174 Id. 175 Id. -34-
Penalties for Non-Compliance
Manufacturers, importers, distributors, and suppliers are all responsible for their product’s compliance with ANATEL regulations. Some examples of violations are:
Non-compliance with ANATEL labeling requirements, or the use of a counterfeit ANATEL Mark;
Submission of fraudulent documentation during the certification application process;
Failure to fulfill conditions of certification; and
Any negligence and/or intentional act that may lead ANATEL or other certification bodies to mistakenly certify a device.176
ANATEL Resolution No. 242 prescribes the following sanctions depending on the degree of the violation:
1st Level – Warning;
2nd Level – Fine;
3rd Level – Suspension of product authorization;
4th Level – Revocation of product authorization;
5th Level – Suspension of accreditation designation (OCDs); and
6th Level – Revocation of accreditation designation (OCDs).177
These sanctions may be applied separately or in combination. Additionally, violators may be subject to fines for any violation of an ANATEL regulation. The fines generally range from R$100.00 to R$3,000,000.00 (USD $24.82 to $744,629.37) depending on the severity of the offense.178
176 See id. 177 Resolution No. 242 at Art. 54. 178 Id. at Art. 61. -35-
INMETRO: INFORMATION TECHNOLOGY AND NON- TELECOMMUNICATIONS RADIOFREQUENCY DEVICES
As noted above, INMETRO has jurisdiction over general product safety standards, and oversees certification of ITE and non-telecom RF-producing appliances.179 Responsible Parties
Manufacturers and importers of the subject RF devices that marketed or imported in Brazil are responsible for ensuring compliance with INMETRO’s regulations.180 These responsible parties must ensure that their products conform to applicable standards, and that they are certified and labeled prior to importing or marketing those products in Brazil.181 Regulated RF Equipment Types
INMETRO certification is required for many household appliances, ITE, RF-producing medical equipment, and low-voltage electrical equipment.182 Testing and Authorization Procedures
Initial Certification
1) Certification Request – The responsible party must apply to one of the INMETRO- accredited certification bodies (“OCPs”) for the certification, and include the following information in its application:
applicant’s name/contact information;
manufacturer’s name/contact information;
description of product/product line (if applicable);
external/ internal photographs;
technical specifications;
user’s manual;
packaging description/ diagram;
selected certification model;
179 See Establishment of INMETRO, Federal Law 5966/73 at Art. 4 (1973); INMETRO Regulatory Powers, Federal Law 9933/99 at Art. 3 (1999). 180 See at Brasil Ministry of Development, Industry & Foreign Trade, FAQ – INMETRO Product Registration at § 1.14 (“FAQ – INMETRO Product Registration”). 181 Id. at §§1.1, 1.14. 182 Product specific Ordinances may be found at the INMETRO website at www.inmetro.gov.br/qualidade/regObjetos.asp. See, e.g., INMETRO, Ordinance No. 371/2009 (Dec. 29, 2009) (household appliances); INMETRO, Ordinance No. 170/2012 (Apr. 10, 2012) (ITE); INMETRO, Ordinance No. 350/2010 (Sept. 6, 2010) (RF-producing medical equipment). -36-
description of consumer complaints process for product defects;
description of the manufacturer’s quality management system (if applicable;
ISO 9001 or ABNT NBR ISO 9001 quality management certification;
import license/ declaration (if applicable); and
other documentation required by the OCP.183
2) OCP Review of Application – The OCP reviews the application and supporting documentation to identify compliance with product-specific INMETRO Ordinances.184 The OCP must notify the applicant of any non-compliance and/or missing documentation/ information, and provide the applicant with the opportunity to rectify any discrepancies.185 Once the OCP completes its initial review, it, if applicable, commences an audit of the manufacturer’s quality management system (“QMS”).186
3) OCP Audit of Quality Management System and Manufacturing Process – Manufacturers of certain products are required to undergo an audit of their QMS. The OCP evaluates the documents and records of the manufacturer’s QMS, and performs an audit on the manufacturer’s premises to verify compliance in accordance with current ISO 9001 standards.187 The OCP’s audit evaluates the manufacturing process to ensure that it is adequately monitored by the manufacturer. Once the audit is completed, the OCP issues an audit report.188
4) Testing – Testing must be done by ILAC-approved testing laboratories, overseen by the certifying OCP.189 The OCP is responsible for establishing specific testing methodologies, but the tests must show that the product complies with the SBAC standards (specific to each product-type).190
If a product fails testing, the applicant must submit to the OCP, within sixty (60) days of notification, evidence of implementation of corrective actions. 191 The applicant is responsible for determining the cause(s) of non-compliance with SBAC standards.192 If the applicant fails to meet the 60-day deadline, the application is cancelled.193 However, the applicant is permitted to reapply for certification in such circumstances.194 The OCP reviews all corrective actions to determine whether they are not suitable for certification.195
183 INMETRO, Ordinance No. 118/2015 (March 6, 2015) at §6.2.1.2. 184 See INMETRO website at www.inmetro.gov.br/qualidade/regObjetos.asp. 185 Ordinance No. 118/2015 at §§6.2.2.2-6.2.2.3. 186 Id. at §6.2.3. 187 Id. 188 Id. at §6.2.3.5. 189 Id. at §§6.2.4.1, 6.2.4.3. 190 Id. at §§6.2.4, 6.2.4.1. 191 Id. at §6.2.5.1. 192 Id. at §6.2.5.2. 193 Id. at §6.2.5.3. 194 Id. 195 Id. at §6.2.5.5. -37-
Additionally, the OCP may order a new QMS audit and/or product testing to determine the suitability of the corrective actions.196
5) Certificate Issuance – After completion of auditing and testing, the OCP reviews the application and testing results to determine whether the product is suitable for certification.197
6) Registration with INMETRO – It is mandatory for manufacturers to register many types of RF products with INMETRO after an OCP certification is issued.198 Registration is required before these products can be imported into Brazil. Products not requiring mandatory registration may be voluntarily registered with INMETRO.
Once an INMETRO certification or a registration is issued, the manufacturer must comply with INMETRO labeling requirements, and is subject to routine maintenance assessments. The duration of the certification or registration varies depending on product type, and the certificate holder must re-apply for renewed certification and/or registration.199 Mutual Recognition Arrangements
INMETRO is a signatory to the November 2, 2000 mutual recognition arrangement ILAC along with the United States and will accept test results from a number of US based laboratories that are parties to the arrangement. Application Fees
The cost for the OCP certification process varies with the individual OCP and by product. If registration with INMETRO is required, an application processing fee of R$60.01 (USD $15.76) is required.200 Certification Application Processing Time
The INMETRO certification processing time varies depending on the nature of the product and the OCP’s procedures. Registration processing typically takes 15 days.201 Labeling Requirements
Products certified by INMETRO must comply with the Brazilian CPC.202 The CPC requires that product labels provide consumers with accurate, comprehensible, precise, and easily readily information regarding the product’s origin, as well as technical and safety specifications.203 Imported products must be translated into Portuguese, and use metric units for any measurements.204
196 Id. at §6.2.5.6. 197 Id. at §6.2.6. 198 The list of products requiring mandatory certification can be found on the INMETRO website at http://www.inmetro.gov.br/qualidade/rtepac/compulsorios.asp (in Portuguese). 199 Id. at §§6.2.6.3, 6.4. See, e.g., INMETRO, Ordinance No. 407/2015 at §5 (Aug. 21, 2015) (Recertification of EMC products every 36 months). 200 See INMETRO website at http://www.inmetro.gov.br/qualidade/taxas-avaliacao.asp. 201 See FAQ – INMETRO Product Registration at §2.6. 202 See generally Consumer Protection Code, Federal Law 8.078/90 (Sept. 11, 1990). 203 Id. at Art. 31. 204 Id. -38-
The INMETRO certification labels vary depending on whether the product is subject to mandatory or voluntary certification, but the label will feature the INMETRO logo and the OCP name and identification number. The INMETRO logo appears as follows:
Additionally, INMETRO-certified products must bear the INMETRO ID Number, and comply with all labeling requirements as set by INMETRO.205 Confidentiality
OCPs are required to treat all product information with strict standards of confidentiality.206 Modifications to RF Equipment
If an INMETRO certification is granted to a specific device, as opposed to a product line, the manufacturer must have the device recertified if it undergoes modification.207 Market Surveillance
Maintenance Assessment
After a RF device receives its initial INMETRO certification, it is subject to routine maintenance assessments. The Maintenance Assessment process is periodically carried out by the certifying OCP to ensure that a certified product continues to fulfill the conditions of its certification.208 The frequency of maintenance assessments is determined by the product-specific INMETRO Ordinance.209
The Maintenance Assessment process is as follows:
1) OCP Audit of Quality Management System and Manufacturing Process – The OCP conducts periodical audits to ensure that the documents submitted in the initial certification process remain accurate and that the manufacturer QMS and manufacturing process remain the same.210 The guidelines and procedures of the audit are the same as the initial certification process; however, the OCP must contact the manufacturer to schedule the audit, unless INMETRO has otherwise established an auditing schedule.211
2) Testing – Testing must be done by ILAC-approved testing laboratories, overseen by the certifying OCP.212 The OCP is responsible for establishing specific testing methodologies,
205 See generally INMETRO, Ordinance No. 274/2014 (June 13, 2014). 206 See Ordinance No. 118/2015 at Appendix A, §§1.10.5. 207 See Ordinance 118/2015 at §§ 6.2.4 (any changes to critical components must be reported to the OCP) and 13.1.6. (manufacturer required to report and changes made to the product post certification). See also FAQ – INMETRO Product Registration at §§4.1-4.4. 208 Id. at § 6.3. 209 Id. at § 6.3 note 1. 210 Id. at § 6.3.1.1. 211 Id. at § 6.3.1.2. See, e.g., Ordinance No. 407/2015 at § 5 (Maintenance Assessments for EMC products every 12 months). 212 Id. at § 6.3.2. -39-
but the tests must show that the product complies with the SBAC standards (specific to each product-type).213
If the product fails testing, the certificate holder must determine the causes of non- conformity, and provide the certifying OCP with a corrective action plan within fifteen (15) days of notification.214 The corrective action plan must have a deadline of sixty (60) days in which to implement any necessary corrective actions.215 Failure to submit the corrective action plan within sixty (60) days will result in the suspension of certification for the product model/ line (depending on the nature of certification).216 The OCP must evaluate the effectiveness of the corrective actions proposed in the corrective action plan, and may re-audit the manufacturer’s QMS and order re-testing of the product to determine compliance.217
3) Confirmation of Certification – The OCP reviews certificate holder’s compliance status based on review of the manufacturers’ records; QMS audits; testing; the treatment of any evidence of non-compliance; any consumer complaints about the products; and any specific conditions set forth in the certification.218 If the OCP’s review is satisfactory, it will then issue the certificate holder a Confirmation of Maintenance certificate.219
INMETRO Market Surveillance
In addition to the OCP’s periodic Maintenance Assessment of certified products, INMETRO performs periodic market surveillance to verify compliance with SBAC standards and certification conditions.220 If INMETRO identifies product non-conformities, it will notify both the certificate holder and the OCP of the issue, and establish any necessary remedial measures.221 Serious non-conformities, if not resolved, may lead to withdrawal of certification and/or penalties.222 Penalties for Non-Compliance
Violation of INMETRO certification requirements, and non-compliance with SBAC standards, may lead to a warning, fine, ban on importing goods, or suspension and/or revocation of certification depending on the severity of the offense.223
213 Id. 214 Id. at §§ 6.3.3.1, 6.3.3.2. 215 Id. at § 6.3.3.2. 216 Id. at § 6.3.3.6. 217 Id. at §§ 6.3.3.4-6.3.3.5. 218 Id. at § 6.3.4. 219 Id. at § 6.3.4.1. 220 See Ordinance No. 118/2015 at § 14 et seq. 221 Id. at §14.3. 222 Id. at §14.5. 223 Id. at §15. See also Establishment of the Powers of INMETRO, Federal Law 9.933/99 at Art. 8 (Dec. 20, 1999). -40-
CANADA
RF Equipment Laws/Regulatory Agency
The Canada Radiocommunication Act (“Act”) 224 and Radiocommunication Regulations (“RCR”) 225 contain the regulatory laws and policies concerning radiofrequency (“RF”) devices in Canada. Most RF equipment that is manufactured, imported, or marketed in Canada is subject to testing, authorization, and labeling requirements.226 Innovation, Science and Economic Development Canada, formerly Industry Canada (“IC” or “ISED”), is the agency that oversees the country’s RF equipment regulatory process.227 Responsible Parties
Manufacturers, importers, distributors and vendors have a legal obligation to ensure that all RF equipment deployed in the Canadian marketplace has been certified or declared to comply with Canadian regulatory standards and that the equipment sold in Canada continues to meet those standards during the entire product life-cycle. Where testing shows that equipment does not comply with an applicable standard, these entities are responsible for taking prompt and effective remedial action.228 Regulated RF Equipment Types
The following types of RF equipment are subject to IC’s technical standards:
Radio apparatus. A device or combination of devices intended, or capable of being used for, radiocommunication (includes a broad range of equipment from remote car alarms to high-powered broadcast transmitters).
Interference-causing equipment. Any device, machinery or equipment, other than radio apparatus, that can cause interference to radiocommunication (includes digital equipment that uses a microprocessor or microcontroller, and Industrial, Scientific and Medical equipment such as switching power supplies used in halogen lamps).
Radio-sensitive equipment. Any device, machinery or equipment, other than radio apparatus, that can be adversely affected by RF emissions (includes consumer electronics and industrial controls).229
Categories of Equipment Subject to Authorization
Category I Equipment must meet technical standards and requires the issuance of Technical Acceptance Certificate (“TAC”). Category I Equipment includes devices such as:
224 Radiocommunication Act, R.S.C., 1985, c. R-2 (Amended June 23, 2015). 225 Radiocommunication Regulations, SOR/96-484 (Amended Apr. 1, 2014) (“RCR”). 226 See Act at §4. 227 See Department of Industry Act, S.C. 1995 c.1 (Amended Dec. 12, 2005) at § 2(1). IC publishes a series of bulletins that elaborate on the Regulations. Many of those bulletins are referenced herein. 228 See Certification of Radio Apparatus, Industry Canada, RSP-100, Issue 11 (Jan. 2016) (“RSP-100”) at §9.1. 229 See Standards and Certification of Radio Apparatus and Electronic Equipment Used in Canada, IC (“Standards and Certification”), http://www.ic.gc.ca/eic/site/smt-gst.nsf/eng/sf01698.html. -41-
broadcasting transmitters, portable radio transmitters, digital scanner receivers, cellular phones, remote car alarms and starters, garage door openers and wireless computer links.230
Category II Equipment must meet certain technical standards, but do not have to be certified. Instead, they are subject to “self-authorization,” a Supplier’s Declaration of Conformity (“SDoC”). Category II Equipment includes: electronic transformers or ballasts, alarm keypads, intelligent battery chargers, satellite TV receivers, VCR's and computers.231
Terminal Equipment must meet technical standards and is subject to another type of self- authorization: a Declaration of Conformity (“DoC”). This category includes virtually any apparatus that interfaces with the telecommunications networks of Canadian carriers.232 Testing and Authorization Procedures
Testing
Category I, Category II, and Terminal Equipment must undergo testing procedures to determine compliance with IC’s technical standards. The standards vary, depending on the specific equipment tested, and Responsible Parties should ensure that the testing labs they employ understand and apply the specific standards required for the individual devices.233 Currently, testing may be done by non- IC accredited labs, but beginning on January 1, 2017, equipment testing must be done by an IC- accredited laboratory only, including IC-accredited foreign testing labs.234
IC will accept test reports that show compliance with U.S. Federal Communications Commission (“FCC”) standards if the report is less than a year old, and a cross-reference table must be provided showing that the equipment meets all of the applicable IC requirements. Where there are differences between the IC and FCC technical standards, supplementary test reports are required to demonstrate compliance with IC standards.235
Certification
In order to for Category I Equipment to be certified, it must be demonstrated that the equipment meets the applicable standards.236 A TAC is issued by IC’s Certification and Engineering Bureau (“Bureau”) or an IC-recognized Certification Body (“CB”), based on the assessment of the test report.237 IC recognizes CBs from countries with which Canada has a Mutual Recognition Agreement (“MRA”). Canada currently has telecom MRAs with the U.S., the European Union countries, European
230 Id.; see also RCR at §21(1)-(4). 231 RCR at § 21(5); see Standards and Certification. 232 See Procedure for the Declaration of Conformity and Registration of Terminal Equipment, Industry Canada, DC-01(E) (June 2014) (“DC-01(E)”) at 1. 233 Id. at 4; RCR at §24. 234 See General Requirements for Compliance of Radio Apparatus, Industry Canada, RSS-Gen, Issue 4 (Nov. 2014) (“RSS-Gen”) at §6.1.2. 235 See Standards and Certification. 236 See RCR at §21(1)-(4). 237 See RSP-100 at §2.2. -42-
Free Trade Association countries, Asia-Pacific Economic Cooperative countries, the Organization of American States’ countries, Israel, Korea, and Switzerland.238
New manufacturers will be required to obtain or use a Canadian Company Number, which new applicants can obtain using the Spectrum Management System.239 To obtain the Company Number,
Click on “Register a new Web Account for a new or existing Licensee or Certification/Registration clients or Broadcaster”. Under the Equipment Certification and Registration list, select “New Applicant” or “New Agent Applicant” and then click on the “Next” button. Fill in the “Web User Information”, “Applicant Information” and “Certification Letter Contact”. Review the information and then submit your request.
For new devices, the applicant must assign a unique model number to the subject device. In some cases, the model number has already been assigned by the manufacturer of a device rather than by the importer or marketer.
The certification process includes:
completion of the IC Application & Agreement for Certification Services (containing name of business, contact information, and other administrative information);
preparation of a cover letter explaining the type of certification services requested and a brief description of the RF equipment;
a complete and signed copy of a Test Report Cover Sheet;
detailed test report meeting the technical requirements of the applicable Radio Standards Specification (“RSS”) (test reports must be retained for 10 years);
a complete and signed copy of Radio Frequency Exposure Compliance of Radiocommunication Apparatus; and
photographs (internal and external) and product literature for the subject model, schematic diagrams and block diagrams, and drawing, sample or illustration of the product label.240
IC typically takes about 14 business days to process and approve certification applications. Depending on the number of applications pending, the processing period may be somewhat shorter or longer.241
Declaration of Conformity
The DoC procedure for Terminal Equipment requires the Responsible Party to submit the following information to the Bureau:
Industry Canada Company Number, if not previously assigned;
238 See Industry Canada Mutual Recognition Agreements/Arrangements at https://www.ic.gc.ca/eic/site/mra-arm.nsf/eng/home (“MRA”). 239 See https://sms-sgs.ic.gc.ca/eic/site/sms-sgs-prod.nsf/eng/h_00011.html. 240 RSP-100 at Annex C (Checklist). 241 See IC FAQs at www.ic.gc.ca/eic/site/ceb-bhst.nsf/eng/h_tt00051.html. -43-
test results – Terminal Equipment must be tested by a domestic testing laboratory recognized by IC or a foreign testing laboratory recognized by IC under an MRA (test results must be retained for 10 years);
letter which provides signed authorization from the Canadian representative used by the Declaring Party (if applicable); and
complete and sign a DoC for the Terminal Equipment, and an Equipment Registration Form.242
Responsible parties are also required to prepare a compliance folder, and submit it to IC upon request. A compliance folder includes the test report, user’s manual, schematic, and sample to the product label.243
Supplier’s Declaration of Conformity
In order to obtain an SDoC for Category II Equipment, the responsible party submits the equipment for testing to ensure that it meets the appropriate technical standards and labels the equipment as required by the standards. Category II Equipment is exempt from certification and registration. Test reports must be retained for five years.244 Application Fees
IC charges $1,200 per certification application, per model. This fee includes a charge for the administration of the application, the technical examination, the review of the brief and the issuance of a TAC.245 IC also requires a “listing fee” of $50 per model, so that the certification information may be listed in IC’s public database, Radio Equipment List.246 For a DoC, IC requires an equipment registration fee of $750.00.247 Labeling Requirements
Certified Devices
The manufacturer, importer or distributor of RF equipment is required to ensure that each certified device is labeled as follows:
label is required to contain a combination of the device’s model number and a certification number;
label must be permanently affixed to the device or displayed electronically and its text must be clearly legible;
if the dimensions of the device are too small or if it is not practical to place the label on the device and electronic labelling has not been implemented, the label shall be, upon
242 See DC-01(E) at §6. 243 Id. at §6.3.3. 244 See MRA. 245 See Telecommunications and Radio Equipment Service Fees of the Certification and Engineering Bureau, Industry Canada, TRC-49, Issue 8 (Nov. 2011) (“TRC-49”) at §3.1. 246 Id. at §3.3. 247 Id. at §3.4. -44-
agreement with IC, placed in a prominent location in the user manual supplied with the device; and
the user manual may be in an electronic format and must be readily available to the user.248
Required Notices to the User
Depending on the type of device, IC may require certain additional information (e.g., warnings) to be listed in a conspicuous place in the user manual or on the device. Suppliers of radio apparatus shall provide the notices and/or statements in both English and French.249
In cases where the applicant has not completed the requirement in this section at the time of equipment certification, the applicant may provide a declaration in writing that the user notices and/or statements to the user of the equipment will be in both English and French at the time each unit of equipment model is offered for sale and/or lease in Canada.250
Devices Subject to DoC
The responsible party must ensure that each device is labeled as follows:
permanently affixing or displaying electronically the registration number and model ID number on the terminal equipment and text must be completely legible;
if the dimensions of the device are too small or if it is not practical to place the label on the device and e-labelling has not been implemented, the label shall be, upon agreement with Industry Canada, placed in a prominent location in the user manual supplied with the device;
the user manual may be in an electronic format and must be readily available; and
a statement of compliance with Industry Canada’s requirements, such as: “This product meets the applicable Industry Canada technical specifications.” 251
Devices Subject to SDoC
The responsible party must label the device as follows:
each unit shall bear a label representing conformity to the applicable standard, e.g., “CAN ICES-3 (*)/NMB-3(*)”;
this label shall be permanently affixed to the device or displayed electronically and its text must be clearly legible;
if the dimensions of the device are too small or if it is not practical to place the label on the device and electronic labelling has not been implemented, the label shall be, upon
248 See RSP-100 at § 3.1; Standards and Certifications. Fees are subject to change. 249 RSP-100 at §4. 250 Id. 251 See DC-01(E) at §6.4. -45-
agreement with IC, placed in a prominent location in the user manual supplied with the device;
the user manual may be in an electronic format and must be readily available; and
a statement of compliance with Industry Canada’s requirements, such as: “This product meets the applicable Industry Canada technical specifications.”252 Confidentiality
Applicants for certification may request confidentiality for the information contained in their applications. Applicants should indicate which information and documents furnished in support of an application for certification are confidential.
The following types of information will typically be granted confidential treatment:
block diagrams;
operational description;
parts lists and tune-up information;
software defined radio (“SDR”) software and security information; and
schematic diagrams.253
For other types of exhibits, IC may consider allowing confidential treatment if the applicant submits an inquiry with appropriate justification before the application for certification is submitted to a CB.254
Regarding equipment subject to DoC, the Responsible Party should indicate which information and documents provided in support of the DoC should be confidential. IC should grant same if the applicable provisions of the Access to Information Act are met.255 Modifications to RF Equipment
Certified Devices
Except as delineated below, most major modifications to Certified RF equipment typically require re- testing and re-certification of same in order to remain properly authorized. The certification holder must inform the CB or IC of any changes that may affect compliance with the technical requirements of the standards under which the device was originally authorized.256
Class I Permissive Change
A Class I permissive change includes modifications that:
252 See Information Technology Equipment (ITE) – Limits and Methods of Measurement, Industry Canada, IECS-003, Issue 5 (Aug. 2012) at §8; 253 See RSP-100 §9.4. 254 Id. 255 See DC-01(E) at §8. 256 See RSP-100 at §7.1. -46-
do not change the electrical characteristics beyond the rated limits established by the manufacturer;
do not change external or internal mechanical characteristics significantly enough to require new photographs to identify the modified radio equipment; and
do not change the model number.257
A Class I permissive change does not require notification to IC or the CB. However, when Class I permissible changes are made, the Certification holder must ensure that its attestation of compliance continues to be valid.258
Class II Permissive Change
A Class II permissive change includes those modifications in the radio equipment that change the electrical characteristics beyond the rated limits established by the manufacturer, without violating the minimum requirements of the applicable standard. A Class II permissive change requires notification to IC or the CB. However, when Class I permissible changes are made, the Certification holder must ensure that the current attestation of compliance continues to be valid.259
Devices Subject to DoC
All devices subject to DoC equipment that are modified must be retested as per the technical requirements in effect at the time of modification, not necessarily those requirements in effect at the time that the equipment was declared. If the modification is major (e.g., changes the Ringer Equivalency Number value) the terminal equipment must be reregistered, using a new model identification number.260
When an applicant requests reassessment for a family of products, models that have reached the end of their production are exempted. In the reassessment request, the applicant must indicate the models that have reached the end of their production.261
Devices Subject to SDoC
IC does not have specific requirements for modification of Devices subject to SDoC, but since all RF devices must operate pursuant to their original authorization, any change in the operating parameters or RF emissions would require the responsible party to retest the device to ensure it is operating as originally authorized. Market Surveillance
Market surveillance is conducted to promote continued compliance of RF equipment with applicable IC regulatory standards, in order to prevent interference, harm to the Canadian public telecommunication networks and to ensure the safety of telecommunications personnel and users.262
257 Id. at §7.2. 258 Id. 259 Id. at §7.3. 260 See DC-01(E) at §6.9.1. 261 Id. at §6.9.2. 262 See MRA. -47-
In the case of certified equipment that requires Certification, CBs are required to conduct market surveillance on at least 5% of the equipment they Certify. If a device fails to comply with the applicable regulatory requirements, CBs are required to notify IC immediately and take all possible actions to resolve the issue.263
The roles and responsibilities of CBs in market surveillance are specified in CB-02, Recognition Criteria, and Administrative and Operational Requirements Applicable to Certification Bodies for the Certification of Radio Apparatus to Industry Canada's Standards and Specifications.264
As an additional check on the integrity of the process, IC conducts a small number of audits each year on Category I Equipment certified by CBs. IC also conducts market surveillance on a small sample of telecommunications equipment that does not require certification (e.g., Category II Equipment).265 Penalties for Non-Compliance
Responsible parties that do not comply with the Regulations may face charges under the Act. An individual may be fined up to $5,000 and/or face one year in prison. Corporations can be fined up to $25,000.266
Any officer, director or agent of a corporation who participated in an offence committed by that corporation is liable to the same punishment (fine and/or jail term) as an individual who is found guilty under the Act.267
263 Recognition Criteria, and Administrative and Operation Requirements Applicable to Certification Bodies (CB) to Industry Canada’s Standards and Specification, Industry Canada, CB-02, Issue 6 (Oct. 2011) (“CB- 02”) at §§6.2.2(a), 6.2.6, 6.2.7. 264 Id at §6.2. 265 See MRA. 266 Standards and Certification at 1. See also Act at §9.1. 267 Id. -48-
CHINA (PEOPLE’S REPUBLIC OF CHINA)
RF Equipment Laws/Regulatory Agencies
China’s radiofrequency (“RF”) equipment regulatory system is governed by three main sets of regulations: (1) The State Radio Regulation Commission Type Approval Regulations (“SRRC Regulations”); 268 (2) Implementation Rules for Compulsory Certification of Telecommunications Equipments (“Terminal Regulations”);269 and (3) Implementation Rules for Compulsory Certification of Electrical and Electronic Products (“ITE Regulations”). 270 Certain environmental and energy regulations also apply to RF equipment. As described below, the individual regulation sets pertain to different categories of RF equipment. As a general rule, the laws mandate that virtually all RF equipment be tested, certified, and labeled before it may be imported or marketed in China.271
China’s bureaucracy respecting RF equipment regulation is somewhat complex. A number of agencies are involved in RF devices.
(a) The Ministry of Information and Industry Technology (“MIIT”) oversees:
The Telecom Administration Bureau (“TAB”) – supervises the Network Access License (“NAL”) process for certain types of RF equipment.272
State Radio Regulation Committee (“SRRC”) – responsible for radio-communications equipment approval regulations associated with the SRRC Certification (i.e., China Radio Type Approval), and radio importation. 273
(b) The General Administration of Quality Supervision, Inspection and Quarantine (“AQSIQ”), administers and is affiliated with:
The Certification and Accreditation Administration of China (“CNCA”) – supervises RF certification and accreditation activities throughout China.
China National Institute of Standardization (“CNIS”) – administers the China Energy Label system.274 Responsible Parties
Manufacturers, including foreign manufacturers, are responsible for obtaining certifications and ensuring regulatory compliance of their RF equipment in China.275
268 SRRC Type Approval (Provisions on the Management of Import of Radio Transmission Equipment) found at www.srrccn.org. 269 Implementation Rules for Compulsory Certification of Telecommunications Equipments, CNCA-08C-031: 2001. 270 Implementation Rules for Compulsory Certification of Electrical and Electronic Products, CNCA-01C-020: 2001. 271 See SRRC Regulations at Art. 4; Terminal Regulations at Arts 1-4; and ITE Regulations at Arts 1-4. 272 See Asia-Pacific Telecommunity Conformity Assessment in China at www.itu.int/en/ITU-T/C- I/interop/Documents. 273 See generally SRRC Regulations 274 See CEL Website at www.energylabel.gov.cn/en. 275 See e.g., SRRC Regulations, Art. 5. -49-
Regulated RF Equipment Types
The three main types of RF equipment subject to regulation in China are:
Radio Transmission Equipment (“RTE”) – consists of products that contain RF transmitters, including wireless handsets and related devices, wireless LAN equipment such as Wi-Fi, radiofrequency identification (“RFID”) and telemetry equipment, and broadcasting devices.276
Information Technology Equipment (“ITE”) – covers devices with microprocessors, including PCs, servers, computer switching power supplies, scanners, chargers, and adaptors.277
Telecommunications Terminal Equipment (“TTE”) – communications or networking equipment that interfaces with the public telephone switched network (“PSTN”) or wide area network (“WAN”) services, including fixed and cordless telephone terminals, fax machines, ISDN terminals, modems, and mobile terminals.278 Testing and Authorization Procedures
SRRC Radio Equipment Importation Permit
An SRRC Radio Equipment Importation Permit must be secured prior to importation of RF equipment into China. Foreign manufacturers of RF equipment must file an “Application Form for the Importation of Mechanical and Electrical Products” to the SRRC, and notify Chinese Customs authorities of its application. After review and approval of the application, the SRRC then directs the relevant Chinese Customs authorities to issue an importation permit, also known as “Certificate for the Importation of Mechanical and Electrical Products.”279
Radio Type Approval
All RTE require a Radio Type Approval (“RTA”) issued by SRRC.280 The procedure to obtain a RTA is as follows:
Submit RF Device and Related Materials for Testing. Manufacturer submits 3-5 samples of each product model, along with additional information to a testing facility overseen by the State Radio Monitoring Center (“SRMC”). The testing standards are specific to China, but they are similar to international standards for these types of devices.281 The following information should be submitted to the SMRC lab:
o Conducted maximum output power;
o EIRP;
o maximum output power;
276 Id. Art. 1. 277 See ITE Regulations Art. 1. 278 See Terminal Regulations Art. 1. 279 Id. Art. 8. 280 See SCCR Regulations Arts. 4-5. 281 See American Certification Body, China Standards (“ABC”) (2014) at 24 -50-
o frequency range;
o occupied bandwidth;
o frequency tolerance; and
o radiated spurious emission.282
Submit an Application for SRRC Certification. Typically, the following materials must be submitted to the SRRC for certification:
o SRRC Application Form;
o test results;
o applicant’s name and contact information;
o applicant’s business license;
o applicant’s ISO Certificate;
o product technical specifications (including schematics, technical specifications, frequency range/ bandwidth, transmitting power);
o external/ Internal photographs;
o user’s Manual;
o trademark attestation (if applicable);
o CE, FCC, or IC report and certificate (if applicable); and
o other documents and materials requested by SRRC.283
Evaluation of Test Report and Issuance of RTA Certificate. The SRRC awards the RTA Certification to an applicant based on whether its application and test results meet the required criteria. The SRRC Certification includes the approval code (“CMIIT”), which (as discussed below) must appear on the product’s label.284
Lead Time and Certificate Validity Period
Lead time for an RTA Certificate is typically six to eight weeks; two weeks for testing and six weeks for approval. Once the applicant receives the RTA Certification and properly labels its subject equipment, that equipment may be imported and marketed in China. An RTA certificate is valid for five years, and can be renewed for an additional three years.
282 Id. 283 See SRRC Regulations at Art. 5, Annex 1, “SRRC Type Approval.” 284 Id. -51-
China Compulsory Certification
China requires that a responsible party obtain a China Compulsory Certification (“CCC”) for TTE and ITE to ensure that they conform to the applicable standard before they may be marketed in China.285 The CCC certification process is as follows:
File Application. Submission of application and supporting materials is made to a certification body (“CB”). The applicable CBs are: (a) for TTES, China Quality Certification Center (“CQC”); (b) for ITE, China Information Security Certification Center (“ISCCC”). The CCC Application must include the following information:
completed CCC Application Form;
contact information for applicant, manufacturer, and factory;
product name, model, and technical specifications;
Original Design Manufacturing or Original Enterprise Manufacturing declaration;
Declaration of Conformity with applicable standard;
product assembly chart, and circuit diagram;
list of critical components and materials;
description of the difference between different product models in the same RF equipment type;
users manual;
product label, and description of label’s location on device;
Factory Inspection Application (if applicable); and
other necessary documents and materials.286
Testing. Testing for conformity with the applicable standard must be performed within China at one of the CNAL-accredited testing laboratories. Concurrent with submission of the application to the CB, the supplier will submit samples of the device to the lab, along with a copy of the user manual, schematics, component information, and any other materials required by the specific lab.287 The lab will review the submitted materials, implement the necessary tests, and produce a test report, which will then be provided to the CB.
Initial Factory Inspection. The CB will send an auditor to the factory which manufactured the device for inspection. The inspection focuses on the quality control process employed
285 See TTE &ITE Regulations, Appendix 5. CCC conforms to the Chinese national standards called Guobiao (“GB”) standards. Typically, the GB standards are harmonized to corresponding standards issued by the International Electrotechnical Commission (“IEC”). 286 Id. Art. 4. 287 Id. -52-
by the factory. Factory inspection guidelines are provided in the CNCA’s official publication of CCC Implementation Rules for each product category.288
Evaluation of Certification Results and Certification Approval – the CB reviews the testing results and the factory inspection report, and determines whether or not to award a CCC. Upon approval the CB will issue a CCC. If denied, the CQC will inform the applicant of the reasons for denial of certification, and the applicant is permitted to re-apply for certification once it has made the appropriate corrections.289
Purchase/ Printing of the CCC Mark. Once the CCC has been issued, the applicant must apply for the certification mark from the CNCA before the products are marketed, imported, or used for any commercial purposes in China.290
Follow-Up Factory Inspection. The CB re-inspects the manufacturing facility every 12 to 18 months.
Lead Time and Mark Validity Period
The lead time for obtaining a CCC Mark can be several months. The application processing, assessment, and certificate issuance typically take only a few days. But, the testing and initial factory inspections often take several weeks. The CCC itself is valid for five years. But, the Mark is valid for one only one year; it must be renewed annually.291
Fees
There are many fees involved in obtaining a CCC Mark, and they are subject to change. A rough breakdown is as follows:
Application – 500 CNY (USD$79) and 1000 CNY (USD$158) translation fee if not in Chinese;
Type Testing – depends on product type;
Factory Inspection – 2500 CNY (USD$394) per day, exclusive of per diem & travel costs (same fees for follow-up inspections);
Approval and Registration - 800 CNY (USD$126) per application;
Renewal for Mark – 100 CNY (USD$15.75) per Mark; and
CCC Stickers – 450 CNY (USD$71) for printing rights and 300 CNY (USD$47.25) each year thereafter & 0.03 to 0.3 CNY per sticker, depending on the size.292
288 Id. 289 Id. 290 See Application form for Purchasing Mark, CQC. 291 [cite] 292292 EUSME China Compulsory Certification, EU SME Centre. -53-
NAL
Manufacturers of RTE and TTE and are required to obtain an NAL.293 The NAL procedure, presided over by the MII’s TAB, is as follows:
Application for NAL Certification. Applicants must submit the following information:
NAL Certification Application Form;
business license of the applicant, manufacturer, and factory (applicant must be a domestic registered company - foreign applicants must have a company branch registered in China);
factory ISO certification;
product technical specifications;
block diagram and schematics;
external/ internal photographs of the product (minimum of 5 photographs);
user’s manual;
SRRC Certificate (if applicable);
Power of Attorney of a local representative; and
other documents that may be requested by TAB.294
Testing. Testing must be done in China by an MII-accredited laboratory. The applicant will need to submit the device for testing prior to or concurrent with the NAL application. Generally, NAL Certification testing includes evaluation of samples and telecommunications specifications, and functionality. Testing specifications are done in accordance with the Chinese GB standards.295 Test results will be submitted to TAB.
Evaluation of Application/ Testing Results and Certification Approval. TAB reviews the testing results and the application, and then issues a NAL Certification to the applicant.296
Purchase of the NAL Mark. The NAL Mark is purchased from the TAB by the applicant.297
Lead Time and Certification Validity Period
Lead time for obtaining an NAL Certificate can be anywhere from six weeks to several months, depending on the test lab’s workload and the number of applications TAB is evaluating at a given time.
293 See ABC at 29. 294 Id. at 32. 295 Id. at 33. 296 Id. at 34. 297 Id. -54-
NAL Certifications are valid for 3 years. Certification renewal applications should be submitted 3 months before the expiration date.298
Restricting the Use of Hazardous Substances
MIIT enforces the Restricting the Use of Hazardous Substances (“RoHS”) measure. 299 RoHS is intended to control the use of toxic substances in many types of products, including many different types of RTE, TTE & ITE (collectively referred to in this instance as Electronic Information Products (“EIP”)). 300 These specific substances are: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers.301
EIP manufacturers are required to ensure that the products they market in China fall below the maximum concentration levels for the toxic substances.302 Manufacturers must undertake their own testing to ensure compliance with the applicable standard.303 Manufactures are also required to self- declare compliance, retain the applicable records, and properly mark their devices (as discussed below).304
China Energy Label
Manufacturers of certain ITE (personal computers, printers, copiers and fax machines), flat-screen TVs and household appliances are required to comply with China’s energy efficient labeling system (“CEL”).305 CEL requires the manufacturer to test its devices to determine their energy efficiency grade, and energy consumption, register with CNIS, and properly label their products.306
CEL Registration
The online CEL registration process requires the following documents in support of the application:
proof of business license (photocopies of same);
company information;
sample of proposed energy efficiency label;
energy efficiency inspection report;
298 Id. 299 See Measures for Administration of Pollution Control of Electronic Information Products, Ministry of Commerce, People’s Republic of China (“RoHS Order”) (May 9, 2006) at Arts. 1-2. 300 Id. at Art. 3. 301 Id. 302 Id. See also Requirements for Concentration Limits for Certain Hazardous Substances in Electronic Information Products, 2006 (“Standard SJ/T 11363-2006”) and Testing Methods for Regulated Substances in Electronic Information Products, 2006 (“Standard SJ/T 11365-2006”). 303 Id. 304 Id.; see also Marking for Control of Pollution Caused by Electronic Information Products, 2006 (“Standard SJ/T 11364-2006”). 305 See CEL Website at www.energylabel.gov.cn/en/; see also Announcement No. 22, 2011 of NDRC, AQSIQ and CNCA (Sept. 14, 2011). 306 Id.; see also Standards GB 28380-2012, GB 1976-2009, and 25956-2010. -55-
trademark license authorization;
application form for labs conducting independent efficiency inspections (for applicants using their own facilities);
OEM statement307
Lead Time and Label Validity Period
The lead time for obtaining approval of CNIS registration approval is approximately six weeks: one week for the testing and four to five weeks for CNIS to review and approve the registration & proposed label. The CEL label does not expire, but the manufacturer must file a Label Use Status Report to CNIS by March 15 each year. The Report must include label filing status of all models, label supervision and punishment status, and status of other relevant energy efficiency label materials.308 Labeling Requirements
China Compulsory Certification (CCC)
The CCC Mark must be affixed to the applicant’s products, and appears as follows:
Alternatively, applicants may apply for self-printing authorization of the CCC Mark. Either way, applicants must comply with the CNCA rules governing the size and appearance of the mark.309
SRRC Certification
Upon issue, the SRRC ID must be displayed on the product line in accordance with SRRC regulations.310
China – SRRC and CMIIT ID
SRRC (State Radio Regulatory Commission of P. R. China) is in charge of issuing the RTA certificate
Approved radio equipment such as mobile phones must be marked with an approval code, known as the CMIIT ID. Since 1st of January 2009, the CMIIT label must have the form MIIT ID XXXXYYZZZ which signifies: CMIIT: Abbreviation for China Ministry of Industry and Information Technology XXXX: Year of approval (e.g., “2011”) YY: A code indicating equipment category. (e.g., “DJ” for a short range devices) ZZZZ: Approval serial number issued by SRRC (State Radio Regulatory Committee). The manufacturer’s name must be
307 See CNIS Guide to Energy Label Registration at 3-4. 308 See Implementation Rules for Energy Efficiency Label, CNIS (“CEL Rules”) at §6.5. 309 See Guide to CQC Product Certification Mark, CQC, www.cqc.com.cn/english/ProductCertification/applicationdownload/webinfo/2006/12/1260497023472604. htm. 310 See China Certification Process at 25-26. -56-
exactly the same as the name in the company registration form. The CMIIT ID is provided on the Type Approval Certificate.
NAL Certification
The NAL Mark affixed to the product, and appears as follows:
The appearance and usage of the NAL Mark must comply with MIIT regulations.311
CQC Certification
After the applicant has received its CQC Certification, it must purchase the CQC Mark and affix it to the approved product. The CQC Mark appears as follows:
CQC Certified products must abide by CQC’s rules and costs concerning the usage of the mark.312 Confidentiality
Individual requests for confidentiality should be made directly to the authorized certification body, and may be awarded on a case-by-case basis. Modifications to RF Equipment
Manufacturers are required to have quality control programs to ensure that any RF equipment not conforming to the authorized samples be taken off the market.313 Any RF device that is modified, repaired or refurbished requires re-testing.314 Manufacturers must keep records of all modifications, repairs and refurbishments.315 Market Surveillance
The CNCA and MII both conduct market surveillance and auditing of China certificate holders to determine compliance. Manufacturers, importers, and retailers of RF Equipment sold in China are all
311 Id. at 34. 312 See Guide to CQC Product Certification Mark, CQC at www.cqc.com.cn/english/ProductCertification/applicationdownload/webinfo/2006/12/1260497023472604. htm. 313 See TTE & ITE Regulations at Annex 5. 314 Id. 315 Id. -57- subject to the enforcement jurisdiction of these agencies, and, accordingly, may be required to provide product test samples on a random basis to determine compliance.316
China Compulsory Certification (CCC)
The CQC conducts annual factory re-inspections for the duration of the certification.317
SRRC Certification
The SRRC generally monitors the marketplace for SRRC Certification holders’ compliance with SRRC regulations, and may suspend a certificate if a product is found not to be in compliance.318
SRRC Radio Equipment Importation Permit
RF Equipment imported into China lacking such a permit will not be permitted to pass Chinese Customs.319
NAL Certification
The MIIT generally monitors the marketplace for NAL Certification holders’ compliance with the relevant regulations governing the NAL Mark, and may suspend a certification if a product is found not to be in compliance.320 Penalties for Non-Compliance
The CNCA and MII both have enforcement agencies, and any findings of criminal conduct by China certificate holders will be turned over to Chinese law enforcement agencies for prosecution. In addition to monetary penalties, criminal charges can be filed in cases of severe safety violations. Additionally, charges against the company’s local representative in China may be brought, and company assets may be seized and forfeited to pay off civil penalties. 321
316 See Market Surveillance in China, SAC/CNCA (2008) at 3. 317 Id. 318 Id. 319 Id. 320 Id. 321 See Regulations for Compulsory Product Certification, Art. 25. -58-
EUROPEAN UNION
RF Laws/Regulations & Regulatory Agencies
In April 2014, the European Parliament and Council of the EU issued a new Radio Equipment Directive (“RED”), intended to harmonize the laws of the Member States regarding authorization and marketing of RF equipment that intentionally transmits or receives radio waves (“Radio RF Equipment” or “RRE”) in the EU.322
RED repeals the current Directive that regulates RRE and telecommunications terminal equipment (“TTE” – equipment that interfaces with the public telecommunications networks of EU Member States): The Radio and Telecommunication Terminal Equipment Directive (“R&TTE”).323 EU Member states were required to publish and apply RED by June 13, 2016.324
This means that all RRE placed on the EU market (i.e.., leaving an EU-based manufacturing facility or clearing customs at an EU-controlled border) must be in compliance with RED and the ancillary Directives.
Beginning June 13, 2017, wired TTE (which is not covered by RED) that is placed on the EU market should be in compliance with the following Directives: (1) TTE Competition Directive (“TCD”);325 (2) Low Voltage Directive (“LVD”);326 and (3) Electromagnetic Harmonization Directive (“EMCD”)327 RRE is also required to comply with LVD and EMCD.328
The European Commission (“Commission”) sets the regulatory framework for the EU telecommunications market.329 Each Member State has its own regulatory agency that implements telecommunications rules, including those involving RF equipment regulation. Those rules must conform to the applicable Directives and Regulations issued by the Commission or other EU regulatory authorities.330 Responsible Parties
Manufacturers, importers, and distributors are responsible for compliance with EU regulations. Each has different duties to perform.331 Some of the specific duties are listed below.332
322 Directive 2014/53/EU (April 16, 2014). RF transmitting-receiving equipment not covered by RED include: (a) amateur radio equipment, including kits and experimental devices; (b) marine equipment; (c) airborne products; and (d) custom-built evaluation kits for use at research and development facilities. Id. at Annex I. 323 Directive 1999/5/EC (April 7, 1999). 324 RED at Art. 49. 325 Directive 2008/63/EC (June 20, 2008). TCD has been in effect for a number of years, and it is assumed that TTE already on the EU market complies with this Directive. 326 Directive 2014/35/EU (Feb. 26, 2014). 327 Directive 2014/30/EU (Feb. 26, 2014). 328 RED at Art. 3. 329 See European Telecoms Rules at https://ec.europa.eu/digital-agenda/en/telecoms-rules. 330 See e.g., RED at Arts. 46-51. 331 RED at Arts. 10-14; LVD at Arts. 6-10; EMCD at Arts. 7-12. 332 These lists are not exhaustive, and some minor differences exist in the various Directives. -59-
Manufacturers
RF equipment manufacturers must comply with the following requirements before placing their equipment on the EU market:
test the subject RF equipment for compliance with EU technical specifications;
ensure that the equipment can be operated in at least one Member State without violating its spectrum use rules;
prepare required technical documentation and perform the necessary authorization procedures.
prepare a self-certification “Declaration of Conformity” (“DoC”) and properly label the device;.
retain authorization records for 10 years after the device has been placed on the market.
have a continuing compliance plan in place.
affix a serial number and other identifying mark on the device (or user’s manual/packaging if device is too small),
include detailed instructions and safety information with their equipment;
include the DoC (or a truncated simplified DoC) with each device sold; and
if restrictions on the use of the device exist in a Member State, provide applicable information in the user’s manual.333
Importers
Regarding RF devices imported into the EU, importers must:
ensure that the manufacturer has properly authorized and labeled the RF equipment, and prepared the necessary technical documentation; prepared the necessary technical documentation;
include the importer’s name/trademark and contact information on the device or, if too small, in the user’s manual or on the packaging;
if importer has reason to believe the subject RF equipment is not in conformity with the applicable rules, it must ensure that it is brought into conformity before placing it on the market;
ensure that when RF equipment is under an importer’s control, it remains in regulatory compliance;
if safety risks exist, importers must test the equipment, investigate, and keep a record of complaints, and recalls, and inform distributors of same; and
333 See RED at Art. 10; LVD at Art. 6; EMCD at Art. 8. -60-
retain DoC and related authorization records for 10 years after the device has been placed on the market.334
Distributors
Distributors have certain obligations regarding RF equipment that they sell and distribute within the EU:
ensure that the RF equipment is properly labeled, and is accompanied by the required documents and user information, and manufacturer and/or importer information;
if a distributor has reason to believe any RF devices are not in conformity with the applicable rules, it must ensure that they are brought into conformity before distribution; and
ensure that when RF equipment is under a distributor’s control, it remains in regulatory compliance.335
An importer or distributor will be considered a manufacturer (and be subject to a manufacturer’s compliance obligations) if it markets RF equipment under its own name or trade mark, or makes any modifications to the equipment that causes it to lose conformity with RED.336 Testing and Authorization Procedures
Radio RF Equipment (RRE)
An RRE equipment manufacturer must perform a conformity assessment procedure (“CAP”) to ensure that, before the equipment is marketed in the EU, it among other things, meets the applicable harmonized standard, 337 will not cause harmful interference, and has an adequate level of electromagnetic compatibility.338 Conformity with the Directive is presumed if conformity with the applicable harmonized standards is demonstrated. 339 There are three CAP methods of which manufacturers can choose; manufacturers should determine which one is applicable for its own requirements.340
Internal Production Control
334 See RED at Art. 12; LVD at Art. 8; EMCD at Art. 9. 335 See RED at Art. 13; LVD at Art. 9; EMCD at Art. 10. 336 See RED at Art. 14; LVD at Art. 10; EMCD at Art. 11. 337 Harmonized standards for RRE and TTE are set by the European Telecommunications Standards Institute (“ETSI”). There are many different standards regarding RF equipment and the manufacturer must ensure that the correct one is chosen when conducting the CAP. See www.etsi.org/technologies- clusters/technologies/regulation-legislation/european-harmonization. 338 See RED at Arts. 3, 16-17. 339 Id. at Art. 14. 340 Id. at Art. 17. -61-
This method requires the manufacturer to: (a) prepare all relevant technical data; (b) test to ensure conformity with the specific technical requirements; (c) properly label the equipment; and (d) draft a DoC and retain same for 10 years after the equipment has been placed on the market.341
EU-Type Examination and Conformity to Type
This method consists of submitting an application to a Commission-approved notified body,342 which will examine the technical design of an RF device and attest that it meets EU requirements. The manufacturer is required to submit an application to the notified body, containing, among other things, detailed technical information about the device, including photos or illustrations of external factors and internal layout, software or firmware used, schematics, and explanations necessary for understanding the technical information and how the device is to be operated. If the application is approved, the notified body will issue a certificate to the manufacturer, and the manufacturer must properly label device, draft a DoC and retain the DoC, certificate and related documents for 10 years after the device is placed on the market.343
Conformity Bases on Full Quality Assurance
This method requires the manufacturer to: (a) design and operate a quality system for design, manufacture, inspection, and test the subject equipment; (b) submit an application for assessment of its quality system to a notified body containing, among other things, technical documentation about the equipment, and detailed information about the quality system, including testing procedures, design specifications, and quality control; (c) if the quality system is approved, properly label the device, draft a DoC, and retain the DoC and documentation pertaining to the quality system for 10 years after the device has been placed on the market.344
TTE
The CAPs for TTE are similar to that of RRE.345 Also, like RRE, presumption of regulation conformity is presumed if conformity with the applicable harmonized standard is demonstrated.346 Fees
The costs associated with testing for compliance, self-certification, and printing of labels will be the responsibility of the manufacturer. Because RF equipment is self-authorized via the DoC, there are no fees required in order to bring such RF devices to the EU marketplace. Declaration of Conformity
A DoC basically a short document wherein a manufacturer describes its subject RF equipment declares that it conforms to the applicable regulations.347 Some additional information is required. The
341 Id. at Art. 17(2)(a); Annex II. 342 The Commission will prepare and release a list of approved notified-bodies. Id. at Art. 31. 343 Id. at Art. 17(2)(b); Annex III. 344 Id. Art. 17 (2)(c); Annex IV. 345 See EMCD at Art. 17; Annex II-IV. 346 See LVD at Art. 14; EMCD at Art. 13. 347 See “Recommended Form of Declaration of Conformity” (EN 45014). -62- required information for a DoC is basically the same for both RRE and TTE, but some additional information is required for RRE:
equipment information (product, type, batch or serial number);
name and address of manufacturer;
Include this statement: “This declaration of conformity is issued under sole responsibility of the manufacturer.”
Include a description of the object of the DoC (i.e. identification of the equipment allowing traceability; it may include a color image of sufficient clarity where necessary for the identification of the radio equipment);
Include this statement: “The object of the declaration described above is in conformity with the applicable Union harmonization legislation:” [List the legislation, such as the RED or TTE]
references to the relevant harmonized standards used
references to other technical specifications in relation to which conformity is declared;
*where applicable, include (a) a description of accessories and components, including software, which allow the radio equipment to operate as intended and covered by a DoC; and/or (b) a statement that the notified body performed [describe the intervention] and issued a certificate.
Additionally, in the signature block, state the place & date where signed.348 Exceptions to Authorization Requirements
In general, RF equipment that is not yet compliant may be displayed at trade fairs and exhibitions, provided that a visible sign clearly indicates that such equipment may not be marketed or put into service in the EU. The operation of such equipment is not technically permitted, but some Member States may allow very limited use (time, location, duration). The relevant authorities in the subject Member State should be contacted if a manufacturer or other responsible party wishes to demonstrate the use of such equipment. Demonstration of radio equipment may only take place provided that adequate measures, as prescribed by Member States, have been taken to avoid harmful interference, electromagnetic disturbances and risk to the health or safety of persons, domestic animals or property.349 Labeling
The CE Mark, which signifies compliance with the applicable standards, must be affixed in a prominent place on all RF devices before they are placed on the EU market.350 For devices subject to the Conformity Based on Full Quality Assurance procedure, the identification number of the subject
348 See RED, Annex VI; LVD, Annex IV; EMCD Annex IV. * Denotes RED requirements only. 349 See RED, Art. 9; EMCD at Art. 5. LVD does not have such a provision. 350 See RED at Arts. 19-20; LVD at Arts. 16-17; EMCD at Arts. 16-17. -63- notified body must follow the CE Mark. 351 In that case, the notified body should affix its identification number, but a manufacturer may do so, with permission from the notified body.352 Market Surveillance
Regarding all RF equipment, if a market surveillance authority in a Member State “has sufficient reason to believe” that a device is a possible risk to the public, it may conduct an investigation. If the authority discovers that the device does not comply with the appropriate Directive, it may order the pertinent responsible party to take corrective action, and/or remove it from commerce. Financial penalties may also be imposed.353 Confidentiality
National market surveillance authorities are under the legal obligation to ensure that information they collect remains confidential to protect trade secrets or personal data, unless such information is deemed vital to protecting the public interest. These items must be made available to the relevant Member State authorities in the course of market surveillance enforcement procedures. 354 Penalties for Non-Compliance
Member States retain the authority to use market surveillance techniques to enforce the Directives. Member States are authorized to determine the penalties for any such violations. The only guidance the Directives provided is that the penalties must be “effective, proportionate and dissuasive.”355 EU Privacy Regulations
IoT companies and equipment manufacturers provide cutting edge products and services powered in no small part by Big Data. To protect their access to and use of valuable data, companies that handle data on European residents must take steps to comply with new privacy and data security regulations that come into force this year.
The General Data Privacy Regulation (“GDPR”) becomes effective on May 25, 2018. Sanctions for breach of the GDPR are steep, and can be as much as four percent of global annual turnover or €20 million, whichever is higher. In this section, we highlight some key elements of the law, and discuss some of the important issues that companies should pay attention to when planning GDPR compliance. Companies are recommended to seek legal counsel to ensure they are fully complying with the new regulation.
Responsible Parties
GDPR applies to all businesses that process data of EU residents (called “data subjects”), even companies outside the EU. The definition of processing is broad, and includes most forms of
351 See RED at Art. 20; LVD at Art. 17; EMCD at Art. 38. 352 Id. 353 See RED, Art. 40; LVD, Art. 19, 354 See Regulation [EC] No. 765/2008 of the European Parliament and of the Council, Setting Out the Requirements for Accreditation and Market Surveillance Relating to the Marketing of Product (July 9, 2008), Article 19. 355 See RED at Art. 46; LVD at Art. 24; EMC at Art. 42. -64- handling or manipulating data.356 For GDPR to apply, processing activities should be related to the offering of goods or services, or monitoring of the behavior of individuals.357
GDPR applies to personal data, which is similarly broadly defined. If a company collects information that refers to a specific person, GDPR will generally consider the information to be covered.358
Compliance requirements
GDPR is replete with new compliance requirements that apply to the numerous ways in which companies collect, use, share, or sell data. The following is a non-exhaustive list of major compliance requirements that will impact IoT businesses in particular:
Notice & Consent
Processing is only lawful when the EU resident gives consent, or for another purpose specifically permitted in the regulation, such as performance of a contract.359 GDPR also requires notice to the EU resident when personal data is collected, with specific required details including who is collecting the data and who will receive the data.360
Why it matters: Today, IoT companies may not always obtain consent or provide notice before collecting information from device users. Some IoT devices passively collect data without user input. GDPR requires rethinking this dynamic.
Data Breach Avoidance & Security
In cases of a data breach, companies must notify authorities within 72 hours.361 The notification must include information about the nature of the breach, communicate details on how to contact the company, describe the likely consequences of the breach, and describe measures being taken to mitigate possible adverse effects.
Why it matters: IoT companies should take steps to avoid data breaches to the extent possible. GDPR includes provisions that may require companies to build privacy into the defaults and design of products, to enforce security measures to protect personal data, and to appoint a data protection officer with oversight over privacy compliance.
Rights
GDPR describes a set of rights that EU residents have, and which companies must respect. These rights are:
356 GDPR, Art. 4. According to the regulation, processing means “any operation or set of operations which is performed on personal data or on sets of personal data, whether or not by automated means, such as collection, recording, organization, structuring, storage, adaptation, or alteration, retrieval, consultation, use, disclosure by transmission, dissemination or otherwise making available, alignment or combination, restriction, erasure or destruction.” 357 GDPR, Art. 3. 358 GDPR, Art. 4. 359 See GDPR, Arts. 6-7. 360 See GDPR, Art. 13. 361 GDPR, Art. 33. -65-
o The right to access information held by a company about an individual.
o The right to rectification of inaccurate information.
o The right to erasure, also known as the right to be forgotten.
o The right to restrict processing of data, for instance, when the processing is unlawful or the accuracy is contested.
o The right to data portability, allowing a person to receive their data and use it with another company.
o The right to object to how data is being used to profile or make decisions concerning the individual.
Why it matters: IoT companies, in consultation with counsel, may determine that compliance with GDPR requires developing user portals or other processes that provide data subjects with access to information, control over the information, and the right to contest the accuracy of information or automated decisions. IoT companies may also be required to develop standard formats and processes that facilitate data portability.
Where to begin?
IoT companies seeking to begin to comply with GDPR will be required to evaluate the data they collect, how they use that data, where it is stored, and the extent to which data subjects have access to the data. Working with legal counsel or a certified information privacy professional, companies can then identify gaps in their privacy practices, and determine how to fill the gaps before GDPR comes into effect in May.
-66-
INDIA
RF Equipment Laws/Regulatory Agencies
India has a number of federal agencies that oversee various aspects of the country’s radiofrequency (“RF”) equipment authorization process. The main agency is the Bureau of Indian Standards (“BIS”), which was established by the Bureau of Indian Standards Act (“Act”)362 to develop RF equipment standards, regulatory markings, and certification programs.363 BIS is overseen by the Ministry of Communications and Information Technology (“MCIT”).
MCIT’s Department of Electronics & Information Technology (“DeitY”) directs the Department of Telecommunications (“DOT”), which in turn is in charge of the Telecommunications Engineering Center (“TEC”). TEC certifies certain electronic telephony devices, such as wireless handsets, modems, and Bluetooth enabled wireless terminals, and equipment connected to the wired Indian telephone network.364 TEC also oversees wireless handset compliance with Specific Absorption Rates (“SAR”) for various types of RF equipment.365
DOT’s Wireless Planning and Coordination Wing (“WPC”) is the national authority regarding spectrum management and licenses wireless communication devices.366 Responsible Parties
Manufacturers of RF equipment, including foreign manufacturers, are responsible for obtaining the required authorizations prior to marketing their devices in India.367 Entities proposing to import RF equipment into India (except for broadcasting receivers and television receive-only satellite Earth stations, “TVRO”) require a license to do so.368 Manufacturers, importers, distributors and marketers are responsible for complying with India’s RF equipment regulatory requirements respecting their roles in the supply chain; licenses are also required for equipment dealers that sell devices that operated in licensed bands, as do commercial end-users that utilize certain types of those devices.369 Regulated RF Equipment Types
The types of RF equipment subject to regulation in India are:
Licensed Wireless Equipment (“LWE”) – consists of wireless and radio equipment that contains a transmitter and that operates in licensed frequency bands (except broadcast
362 The Bureau of Indian Standards Act, 1986, No. 63 of 1986 (Dec. 23, 1986). 363 Id., Ch. IV, §10. 364 See Telecommunications Engineering Center, www.tec.gov.in/tec-functions/ (“TEC Functions”). 365 See TEC SAR Lab website at http://www.tec.gov.in/sar-lab/. 366 See Department of Communications, Wireless Planning & Coordination Wing, http://www.wpc.dot.gov.in/ (“WPC Functions”). 367 See e.g., India.gov.in Archive www.archive.india.gov.in/sectors/consumer_affairs/index.php?id=13 (“BIS Index”) at ¶ 6 368 See www.wpc.dot.gov.in/faq.asp (“WPC FAQ”). Application for License to Import Wireless Transmitting and/or Transreceiving Apparatus into India, is available at WPC website at www.wpc.gov.in/WriteReadData/userfiles/file/importappl.doc. 369 End-user “non-network” licenses are required for operation of amateur radio equipment, hand-held short-range UHF devices, global maritime distress and safety systems, and aeronautical equipment. See WPC FAQ. -67-
receivers and TVROs). This includes wireless handsets, wireless LAN equipment such as Wi-Fi, Bluetooth devices, and WiMAX devices.370
Unlicensed Wireless Equipment (“UWE”) – low power wireless devices that operate in unlicensed frequency bands devices. Unlicensed frequency bands include: 2.4 GHz, 5 GHz, 865-867 MHz, 335 MHz, 26.957-27.383 MHz.371 Equipment includes radiofrequency identification (“RFID”) devices, telemetry equipment, and local area network (“LAN”) devices.372
Telecommunications Terminal Equipment (“TTE”) – communications or networking equipment that interfaces with the public switched telephone network (“PSTN”) or wide area network (“WAN”) services, including fixed and cordless telephone terminals, fax machines, ISDN terminals, modems, and mobile terminals, as well as various types of wireless equipment.373
Information Technology Equipment (“ITE”) – devices that contain a microprocessor, including PCs, laptops/notebooks/tablets, electronic games, printers, power adaptors for ITE & A/V equipment, scanners, smart card readers, sealed secondary cells/batteries for use in portable applications, and set-top boxes.374 Licenses, Testing and Authorization Procedures
WPC Licenses/Authorization
Dealer Possession License
All prospective dealers and distributors of any type of wireless product are required to have a Dealer’s License to Possess Wireless Receiving or Transmitting Apparatus in India (“DPL”).375 The application for a DPL consists of supplying WPC with some contact information about the applicant, location of the wireless equipment, and the equipment itself.376 A DPL is good for one year, and must be renewed each December 31.377 Fees for the DPL must be paid quarterly; totaling 150 Rs. each year.378
Non-Dealer Possession License
A Possession License for Wireless Receiving and/or Transmitting Apparatus for a Non-Dealer (“NDPL”) must be obtained by all non-dealer individuals or businesses that propose to possess wireless equipment and that do not have any other type of license respecting wireless equipment.379 The application for an NDPL is similar to that of a DPL, and fees for this license also must be paid quarterly
370 See WPC FAQ. 371 See WPC Website at www.wpc.dot.gov.in/Static/sublegislation.asp for individual orders establishing unlicensed bands. 372 Id. 373 See Electronics & Information Technology Goods (Requirements for Compulsory Registration), Ministry of Communications and Information Technology, Order, S.O. 2357(E) (Sept. 7, 2012), at Schedule 1. 374 Id. 375 See WPC, Guidelines for Possession License, at ¶ 1. 376 See WPC, Application for a License to Possess Wireless Receiving and or Transmitting Apparatus in India. 377 See WPC, Guidelines for Possession License, at ¶ 6. 378 Id. at ¶ 7. 379 Id. at ¶ 1. -68-
– totaling 37.5 Rs. for a year.380 WPC requires an NDPL applicant to obtain security clearance from the local police.381 WPC anticipates that NDPLs will be issued for a year or less; good reason must be presented to WPC for renewal.382
Import License
An import license is required, prior to the importation of any type of wireless equipment, with the exception of broadcasting receivers and TVRO systems.383 The importation application process is complex, and the information requirements are different, depending on the type of applicant and equipment imported. Examples include:
Licensed Users (for LWE)
import license application;
copy of signed purchase order from end-user (which must have a Decision Letter or Frequency Earmarking Letter from WPC);
copy of the Decision or Letter or Frequency Earmarking Letter;
technical information about equipment (must match that in applicable Letter);
high Sea Sales Agreement (if applicable);
details of equipment imported within the past year and utilization of same;
security clearance; and
type approval certificate for GSM/CDMA wireless equipment;
DPL Holders (for LWE)
Same as above, plus copy of DPL and equipment must be in the DPL list of equipment.
UWE
import license application;
copy of signed purchase order from applicant to foreign supplier;
copy of signed invoice from supplier to applicant;
technical information; and
copy of type approval for equipment operating in the 2.4 GHz/5 GHz bands.384
380 Id. at ¶ 7. 381 Id. at ¶ 15. 382 Id. at ¶ 16. 383 See e.g., India.gov.in Archive archive.india.gov. in/sectors/consumer_affairs/index.php?id=13 (“BIS Index”) at ¶ 6. 384 See WPC Checklist, available from WPC website at wpc.dot.gov.in/DocFiles/checklist/check%20list.doc -69-
Import licenses are good for six months and they may be extended for additional six month periods. The fee for an initial import license and renewals is 500 Rs (USD$7.72)385
Lead time for any WPC license or authorization is typically four to six weeks. But, circumstances can arise that will delay the processing of application.386
Equipment Type Approval
All UWE is required to be type approved prior to marketing or importation into India.387 Applications are available from WPC, and must be submitted to the Wireless Advisor, Government of India.388 The Equipment Type Approval (“ETA”) application includes:
test report from accredited testing lab, demonstrating technical compliance with applicable standards;
name and contact information and Indian agency (ETA will only be granted to an Indian entity and not a foreign manufacturer);
certificate of Authorization for Indian agency;
technical details about the transmitter and receiver; and
for outdoor applications, if an antenna is more than five meters above the rooftop in the proposed operational area, proof of antenna site clearance is required from the Standing Advisory Committee on Frequency Allocations (“SACFA”).389
TEC Authorizations
Type Approval
TTE that corresponds to TEC’s Generic Requirements (“GR”) requires type approval from the agency prior to marketing or importation into India.390 Nearly all TTE is subject to GR.391 Type approval is given after evaluating the sample of product for compliance to its GR.392
Eligible type approval applicants are:
Indian manufacturers;
100% Indian owned importers, distributors or dealers;
importers, distributors or dealers established in India with any level of foreign equity, as long as they have the objective of importing and selling the equipment in India; and
385 See WPC Order No. J-14025/200(14)/05-NT (July 17, 2007). 386 See “Imports of Wireless Devices to Face Delay, The Economic Times (Sept. 6, 2014). 387 See WPC Order No. R11020/02/2008-R (Feb. 2, 2008). Mobile phones are also required to be type- approved; procedure is under the ITE rules, described below. 388 See WPC Memorandum J-22022/01/2007-WF (Feb. 1, 2007). 389 Id. at ¶ 2. 390 See TEC Website at www.tec.gov.in/type-approval/. 391 Id. 392 Id. -70-
foreign companies having their wholly owned subsidiaries in India for trading activities.393
Type approval applications must include:
cover letter;
main form application;
equipment sample;
test reports (must be from Indian-accredited test lab);
certificate of incorporation and/or proof of company’s registration in India;
foreign collaboration documentation (e.g., MOU or distributorship agreement);
technical specifications of equipment;
user’s manual;
technical information such as installation and maintenance instructions;
affidavit, with attestation by notary public; and
for importers, dealers, and distributors, authorization letter from manufacturer, appointing them as agent for the specific purpose (include MOU if applicable).394
Lead time for type approval certificates can be several months, or longer, depending on the thoroughness of the application. Fees vary, depending on the type of device.
Interface Approval
TTE that corresponds to TEC’s Interface Requirements (“IR”) requires interface approval from TEC prior to marketing or importation into India.395 Many types of TTE are subject to interface approval.396 Interface approval is given after evaluating the sample of product for compliance to its IR.397
Eligible interface approval applicants and Indian manufacturers include; authorized importers, dealers, or distributors of a foreign manufacturer; or branch office of a foreign manufacturer having permission from the Reserve Bank of India to import and sell its devices.398
Interface approval applications are very similar to those of type approval applications; same type of documentation is required, in this case demonstrating IR compliance.399
393 Id. 394 Id. 395 See TEC Website at www.tec.gov.in/interface/. 396 Id. 397 Id. 398 Id. 399 See TEC Website at www.tec.gov.in/interface/2/. -71-
Like type approval certifications, lead time for interface approval certificates can be several months, or longer, depending on the thoroughness of the application. Fees vary, depending on the type of device. The term of certifications vary and must be renewed.400
Certificate of Approval for GMS phones, 3G modems, and Bluetooth Enabled Wireless Terminals
There is a special certification of approval (“Special Certificate”) for the above-listed devices for which a GR/IR does not exist with TEC, and the applicant has obtained the requisite standards approval from an international accreditation authority.401 Eligible entities are the same as listed in the Interface Approval section.
Applications (must be in English) for a Special Certificate typically include:
test report and Full Type Approval from the international accredited lab;
copy of MOU (if applicable);
Certificate of Conformity;
technical documents, including testing methodology;
declaration from manufacturer that applicable standard(s) have been met;
declaration from manufacturer that applicable security measures have been taken to prevent unauthorized changes in the equipment identity ;
trade authorization letter from manufacturer;
affidavit, attested by notary public; and
original model of equipment, including model number.402
Fee for Special Certificate is 35,000 Rs. Lead time is typically several months. Certifications have varying terms and must be renewed.403
BIS Registration
Manufacturers of many types of ITE, as well as mobile phones, are required to register with BIS and self-certify compliance with the applicable safety standards before the equipment may be imported into or sold in India.404 The process is as follows:
test device for compliance at a BIS Recognized Laboratory;405
400 See Terms and Conditions of Certification at ¶ 5. 401 See TEC Website at www.tec.gov.in/certificate-of-approval. 402 Id. See also TEC Website at www.tec.gov.in/certificate-of-approval/2/. 403See Terms and Conditions of Certification, at¶ 5. 404 See Ministry of Communications and Information Technology (Department of Electronics and Information Technology), Order, S.O. 2357(E) (Sept. 12, 2012) (“Compulsory Registration Order”) at ¶ 3. A complete list of equipment types subject to registration is contained in Schedule I thereto. 405 A list of approved testing labs is found on BIS Website (www.bis.org.in). -72-
download application & self-declaration documents (Forms VI, VII & VII) from BIS website & complete same (application requires contact information, model number, technical information, information about manufacturing plant, quality control staff, and technical information about the device) – application must be signed by manufacturer CEO and, if manufacturer is foreign, countersigned by Indian representative; and
include the following documents with the application:
o test report (less than 90 days old);
o authorization letter;
o government authorization document, authenticating manufacturer’s name and address;
o process flow chart;
o manufacturer management chart;
o cover letter from manufacturer;
o directions to the manufacturing facility from the closed airport or train station; and
o any details about previous certifications cancelled or rejected by BIS
After Grant of Registration, submit Agreement for Grant of Registration (on BIS website).406
The registration processing fee is 28,000 Rs. (USD$437). 407 Lead time can vary significantly, depending on the workload of the laboratory reviewing the application. 408 An initial Grant of Registration is good for one year409 and may be renewed for additional terms of one or two years each, depending on the product.410 BIS Labeling Requirements
Upon Grant of Registration, the applicant will receive a Registration Number. All devices so registered will be required to contain a label with the following information: “Self Declaration – Conforming to [standard number]. Registration No. XX.XX.”411 The label should be indelible, legible, and clearly visible on the device. If it is not possible to affix the label to the device, it may be located on the packaging.412
406 See BIS Website at www.bis.org.in/cert/ProcGrantReg.asp. 407 See www.bis.org.in/cert/RegistrationFee.pdf. 408 See http://220.156.188.9/BIS/app_srv/tdc/gl/pdf/FAQ.pdf. 409 See BIS Website at www.bis.org.in/cert/prod_cert_scheme.asp. 410 See BIS, Central Marks Department-3 (SDOC), Ref. CMD-3(SDOC)/CRS/E & IT Goods (Jan. 28, 2015) available at www.bis.org.in/cert/CRS-Validity_29012015.pdf. 411 See BIS, Central Marks Department - SDOC, Order, Sub: Labeling Requirements for Self-Declaration of Conformity under Compulsory Registration Scheme for Electronics & IT Goods, BIS/DGO/(405)/2014 (July 31, 2014) available at www.bis.org.in/cert/Labelling_July_Rev_01.pdf. 412 Id. -73-
Modifications of RF Equipment
WPC, TEC and BIS have no provisions regarding modifying authorized equipment. Accordingly, any change to the operating characteristics of an RF device requires re-authorization. Enforcement
BIS conducts market surveillance to ensure that products are properly labeled and will do periodic inspections to determine if a product meets the applicable standard. Licensees are responsible for the cost of such inspections and corresponding tests. Failure to meet the standard requirements will result in termination of the registration. Improper use of the BIS label is punishable by imprisonment of one year, a fine of 50,000 Rs. (USD$770) or both.413 TEC, through its SAR Lab, conducts periodic tests of mobile handsets to ensure that they meet the SAR standard.414 Use Operation or possession of wireless devices without authorization is punishable by fine or imprisonment by the WPC.415
413 See BIS Act, 1986, Section 33(1). 414 http://www.tec.gov.in/sar-lab/. 415 See WPC, Manufacturing and marketing of Wireless Telegraphy apparatus – reg, No. R-11014/8/99-LR (09/08/1999). -74-
JAPAN
RF Equipment Laws/Regulatory Agencies
There are several Japanese laws and agencies that regulate the manufacture and distribution of radiofrequency (“RF”) equipment. Each has its own authorization requirements, although certain types of equipment require authorizations under multiple laws. Japan also has a voluntary certification process that is established by a council of technology industry companies.
The Radio Law contains the rules and policies regarding the regulation of RF equipment in the country.416 The Radio Law created the Ministry of Internal Affairs and Communications (“MIC”), which oversees the regulation of RF products.417 MIC appoints Registered Certification Bodies (“RCBs”) to perform testing and certification of RF equipment.418
The Telecommunications Business Law regulates telephony terminal equipment (“TTE”) connected to the public telephone network by wire or radio.419 MIC also oversees the regulation of these devices.
Conformity Approval Bodies (“CABs”) certify terminal equipment under the Telecommunications Business Law.420 Certain equipment, such as mobile telephones, requires certification under both the Radio Law and Telecommunications Business Law.
The Electrical Appliances and Materials Safety Law established consumer safety standards for specific electrical appliances sold in Japan.421 The Japan Ministry of Economy, Trade and Industry (“METI”) oversees the safety regulation. Manufacturers and importers of covered electrical appliances must obtain a Product Safety Electrical certification (“PSE Certification”) for their products.422
Finally, the Voluntary Control Council for Interference by Information Technology Equipment (“VCCI”) verifies EMC emissions of RF equipment.423 RF equipment importers and manufacturers may obtain a certification from VCCI to demonstrate that their products will not cause interference to other RF equipment. Responsible Parties
Manufacturers and importers of RF equipment to be sold and operated in Japan are subject to the rules and regulations governing technical regulations conformity (“TRC”), terminal equipment approvals and PSE Certifications.424 VCCI Certification is limited to manufacturers, importers, and
416 See Radio Law (Law No. 131 as of May 2, 1950), as amended by Law No. 21 of 2005, Art. 38. 417 Id. at Art. 38-2-2(1). 418 Id. at Art. 38-6(1). 419 Telecommunications Business Law (Law No. 86 as of December 25, 1984) as amended by Law No. 136 of December 28, 2007, Art. 53. 420 Id. 421 See Electrical Appliances and Materials Safety Law, Law No. 234 of November 16, 1961, as amended, at Art. 1 (“EAMSL”). 422 Id. at Art. 10. 423 VCCI Council at www.vcci.jp/vcci_e/. 424 See Radio Law, Art. 38-2 (1)(i)-(iii); see also EAMSL, Art. 38. -75- retailers of information technology equipment (“ITE”) in Japan who are members of the VCCI, and pay annual dues to the organization.425 Regulated RF Equipment Types
Specified Radio Equipment
Certain types of RF equipment must obtain a Technical Regulations Conformity (“TRC”) Certification under the Radio Law in order to be manufactured or marketed in Japan.426 There are three categories of Specified Radio Equipment (“SRE”) subject to the TRC Certification:
Unlicensed Devices (e.g., PHS terminals, digital cordless phones, Bluetooth-enabled devices);427
Blanket Licensed Devices (e.g., cellular telephones);428 and
Other Devices (e.g., amateur radio equipment).429
Special Specified Radio Equipment
Most RF equipment is subject to certification, but certain types of equipment that have a low risk of interference such as cordless phones and terminal equipment, referred to as Special Specified Radio Equipment (“SSRE”) may be “self-certified” via a “self-confirmation of technical regulations conformity” or supplier’s declaration of conformity (“SDoC”).430
Telecommunications Terminal Equipment
TTE is subject to the self-certification process described below.431
Electrical Appliances and Materials
Electrical appliances and materials (“EAM”) are parts of electrical facilities for general use and machines, appliances, and materials used in connection therewith; portable power generators; and
425 VCCI, Rules for Voluntary Control Measures, V-2/2015.04 at Arts. 2-3 (April 1, 2015) at www.vcci.jp/vcci_e/activity/regulation/y15/kitei02_1504.pdf (“VCCI Rules”). 426 Radio Law at Art. 38-6(1). 427 Radio Law at Art at 38-2(1)(i). A list of the various types of equipment regulated by the MIC can be found at /www.tele.soumu.go.jp/e/sys/equ/tech/techobj/index.htm (“MIC Website”) 428 Id. at Art. 38-2(1)(ii). 429 Id. at Art. 38-2(1)(iii). 430 See Radio Law at Art. 38-33(1)-(2). See also MIC, Technical Regulations Conformity Certification System, §§ 2 and 4, available at www.tele.soumu.go.jp/e/sys/equ/tech/ (“TRCC System”). Special Specified Radio Equipment is defined pursuant to Art. 2(2), Ordinance Concerning Technical Regulations Conformity Certification etc. of Specified Radio Equipment (Ministerial Ordinance of Ministry of Posts and Telecommunications (MPT) No. 37 of 1981) (“Ordinance of MPT No. 37 of 1981”). See MIC Website for a list of SSRE. 431 See Overview of Certification System for Terminal Equipment in Japan, Telecommunication Systems Division, Telecommunications Bureau, MIC (February 27, 2013) www.tele.soumu.go.jp/resource/j/equ/mra/pdf/24/e-06.pdf (“Terminal Equipment Overview”). -76- secondary batteries.432 Electrical facilities are those that are connected to a 100 V or 200 V AC commercial power supply in households, most offices and agricultural workplaces.433 DC operated appliances are not designated as electrical appliances and materials.434 Over 450 products are subject to PSE Certification requirements under the EAMSL. A portion of the products are singled out because of their potential for interference or electrical hazard.435 All other devices are “non-specified” or “other.”436
Information Technology Equipment
VCCI Certification is limited to ITE sold, imported, and/ or manufactured by active VCCI members.437 There are two types of RF equipment certified by the VCCI Council: Class A and Class B equipment.438 Each class is separated by specific interference limits.439 Class A equipment is generally commercial or industrial equipment. Class B equipment is generally consumer electronics and telecommunications equipment, including portable equipment powered by built-in batteries, telecommunication terminal equipment powered from a telecommunication network, laptops, and fax machines.440 Testing and Authorization Procedures
TRC Certification
Responsible Parties obtain TRC Certification for their RF equipment through an MIC-approved RCB.441 Respecting SSRE, TRC Certification may also be obtained through a self-certification process.442
RCB Certification Process
Obtaining TRC Certification via the RCB Certification Process typically is as follows:
o TRC Certification Application. The application is submitted to a laboratory accredited by an RCB. The application must include a complete technical description of the product and measurement report showing compliance with MIC’s technical standards. However, application formats are typically dictated by the specific RCB-approved laboratory.443
432 Electricity Business Act (Act No. 170 of 1964) (“EAMSL”) at Art. 2(1). 433 See METI, Product Safety Division, Electrical Appliances and Materials Safety Act, Statutory Operations Implementation Guide, For Manufacturers/Importers, 2nd version, § 1.1.1., pg. 2 (January 1, 2014) (“PSE Guide”). 434 Id. 435 EAMSL, Art. 2(2). 436 A list of all products and their designation can be found at METI’s website. www.meti.go.jp/english/policy/economy/consumer/pse/index.html. 437 See VCCI Rules at Arts. 2-4, 9.4 (“VCCI Rules”). 438 Id. at Art. 5. 439 Id. at Annex I, Technical Requirements. 440 Id. at Art. 5.1. 441 See TRCC System (certification process, and list of approved RCBs). 442 See Radio Law at Art. 38-33. 443 Id. at Art. 38-31. -77-
o Testing. Testing is conducted by an RCB-approved laboratory on one sample unit for each type of radio equipment. This is known as the Construction Design Attestation System.444
o RCB Approval and Grant of TRC Certification. After testing is completed, the RCB will review the testing results and application. The TRC Certification is then awarded if the RF equipment conforms to the MIC’s regulations. An applicant may appeal RCB decisions that a product does not meet requisite standards to the MIC.445
Grants of TRC Certifications are reported by the RCB to MIC, and are on file with MIC for a period of five to ten years, depending on the granted Certification.446 Renewals must be sought from the MIC.447
SDoC Certification Process
Upon verification that the SSRE conforms to MIC’s technical regulations, a manufacturer or importer can then notify the MIC that it self-certified its product.448
Terminal Equipment Approval
MIC establishes technical standards for TTE.449 Manufacturers of TTE must submit the products to CABs for a Technical Conditions Compliance Approval which certifies that the equipment meets applicable MIC standards.450 The CABs will notify MIC if a product has been approved.
Manufacturers may self certify certain terminal equipment that MIC has established by ordinance that does not pose a significant danger to telecommunications circuit facilities (“Specified Terminal Equipment” or “STE”).451 After testing the STE to determine it meets MIC standards, the manufacture must submit a notice to MIC that includes:
the name and address of the manufacturer;
the class and type of Specified Terminal Equipment;
a description of the test results;
a description of the testing method; and
any additional information that MIC mandates be included for the specific Specified Terminal Equipment.452
444 Id. at Art. 38-2-24. 445 Id. at Art. 38-14(1). 446 Id. at Art. 38-4(1). 447 Id. 448 TRCC System, § 2. 449 Telecommunications Business Law at Art. 52.1. 450 Id. at Art. 53(1). 451 Id. at Arts. 63(1) and (2). 452 Id. at Arts. 63(3)(i-v). -78-
Manufacturers must retain their testing records and a copy of the notice to MIC.453 MIC will issue a public notice stating that it received the STE notice.454
PSE Certification
Responsible Parties must notify METI within 30 days of manufacturing or importing EAM into Japan.455 The notification must include identifying information about the company, the category of appliances or materials, and the name and location of the plant or business site where the product is manufactured.456 Notifying suppliers must also obtain a PSE Certification from METI.
The PSE Certification process is different for Specified Electrical Appliances and Materials and Non- Specified Electrical Appliances and Materials457:
Specified Electrical Appliances and Materials
o Certificate of Conformity. The notifying supplier must submit samples of the product or material for testing to a CAB registered with METI to confirm that the device conforms to the EAMSL’s technical standards. Each CAB has different application requirements. The CAB will issue a certificate of conformity to the successful applicant. 458 Once testing is completed, the CAB will issue the manufacturer a PSE Certification, and the appropriate PSE Mark may be placed on the product.459
Non-Specified Electrical Appliances and Materials
o Self Certification. A notifying supplier must test the non-specified electrical appliance or material to ensure the product meets METI’s standards for that specific product and retain the results of the test.460 Once testing is completed, the manufacturer has obtained its PSE Certification, and may place the appropriate PSE Mark on its product.461
VCCI Certification
To obtain the VCCI Certification, the RF equipment must meet the product specific VCCI technical requirements, with testing being performed at laboratories registered with the VCCI.462 The VCCI
453 Id. at Art. 63(4). 454 Id. at Art 63(6). 455 EAMSL, Art. 3. 456 Id. 457 See Electrical Appliance and Material Safety Law, Japan Ministry of Economy, Trade and Industry at www.meti.go.jp/english/policy/economy/consumer/pse/index.html. 458 Id. at Art. 9. See also Foreign Registered Conformity Assessment Bodies, Japan METI at www.meti.go.jp/english/policy/economy/consumer/pse/07.htm (list of CABs). 459 See Mark Affixed at www.meti.go.jp/english/policy/economy/consumer/pse/09.htm. 460 EAMSL at Art. 8(2). 461 See Mark Affixed 462 See VCCI Rules at Art. 8. -79- member then submits the test results along with an application for registration to VCCI.463 Upon receipt of the registration, VCCI will provide the member with an Acknowledgement of Reception.464 Application Fees
TRC Certification
TRC Certification application fees vary depending on the RCB, and the RF equipment type. However, there is no fee for self-certification.
Terminal Equipment Approvals
TRC Certification application fees vary depending on the registered approval body, and the RF equipment type. However, there is no fee for self-certification.
PSE Certification
Certification fees for testing of Specified Electrical Appliances and Material vary by CAB.465 There is no fee for the self certification of Non-Specified Electrical Appliances and Materials.
VCCI Certification
There is no fee to request a certification from the VCCI Council; however, applicants are required to obtain a VCCI membership. Applications for membership must be submitted with a filing fee of ¥54,000. 466 Annual membership fees vary depending on the number of certifications that are requested and if the member has executive officers that are also executive officers of the Japan Electronics and Information Technology Industries Association (“JEITA”), Japan Business Machine and Information System Industries Association (“JBMIA”) and/or Communications and Information network Association of Japan (“CIAJ”). The annual fees range from ¥108,000 to ¥864,000. All of these fees include an 8% consumption tax (subject to increase). There is also a bank processing fee of ¥2,700 (with 8% consumption tax) for each transaction.467 Certification Application Approval Time
TRC Certification
Application processing times vary widely depending on the certification body.
Terminal Equipment Approvals
Application processing times vary widely depending on the certification body.
463 Id. at Art. 9.3. 464 Id. Art. 9.2. 465 See PSE Guide, at § 5.2(2). 466See VCCI Approval, VCCI membership application, VCCI, at www.vcci.jp/vcci_e/general/join/index.html. 467 Id. -80-
PSE Certification
Application processing times vary depending on the CAB selected to test the Specified Electrical Appliances and Materials. There is no processing time related to the self-certification of Non-Specified Appliances and Materials.
VCCI Certification
Generally, it takes about one week to issue a verification of acceptance of the Conformity Verification Report following testing.468 Labeling Requirements
TRC Certification
Once the radio equipment has been certified, the TRC Certification mark and additional information shall be placed on the equipment. The mark and information are:
● Specified Radio Equipment: R [Certifying Body ID] [Device ID] [Certification No.]469
Terminal Equipment Approvals
The mark and identification information for Specified Terminal Equipment is slightly different. It is as follows:
● Specified Terminal Equipment: T [Terminal Equipment ID] [Year] [Sequential No.] [Certifying Body ID]470
PSE Certification
Once testing is complete, the manufacturer’s PSE Certification is fulfilled, and the manufacturer must then affix the PSE Mark on its products in accordance with its product type:
Specified Electrical Appliances and Materials:
Additionally, Specified Electrical Applicances and Materials must also identify the CAB that conducted the conformity assessment, the notifying supplier, and the product ratings established by METI.471
Non-Specified Electrical Appliances and Materials: .
468 See VCCI Council, VCCI Guide at 5.2 Note (April 2014) at www.vcci.jp/vcci_e/general/join/nyuukai_annaie.pdf. 469 See Certification System for Telecommunications Equipment in Japan, Electromagnetic Environment Division, Telecommunications Systems Division, Telecommunications Bureau, MIC, pg. 12 (March 25, 2010), www.tele.soumu.go.jp/resource/j/equ/mra/pdf/21/a01.pdf. 470 Id. 471 See Ministerial Ordinance Specifying Technical Requirements for Electrical Appliances and Materials, Ordinance of the Ministry of International Trade and Industry No. 34 of July 1, 2013, Art. 17. See also PSE Guide at §6.4. -81-
Additionally, Non-Specified Electrical Applicances and Materials must also identify the notifying supplier and the product ratings as established by METI.472
Equipment receiving a PSE Certification must comply with the METI’s labeling requirements as may be established from time to time.473 Additional labeling requirements apply to products deemed to cause additional hazards as they age or through prolonged use.474 Furthermore, certain electrical appliances are subject to labeling under the Household Goods Quality Labeling Act of 1962.475
VCCI Certification
Once the VCCI issues an applicant a certificate of compliance, compliant RF equipment must be marked with the VCCI mark or label.
Class A equipment may be labeled with the following warning:
この装置は、クラス A 情報技術装置です。この装置を家庭環境で使用する と電波妨害を引き起こす ことがあります。この場合には使用者が適切な対策 を講ずるよう要求されることがあります。 VCCI-A
[Translation: In a domestic environment this product may cause radio interference, in which case the user may be required to take corrective actions. VCCI-A] or the following mark:
476
Class B equipment is to be labeled with the VCCI mark.477
Equipment that whose testing is limited to a particular testing site must include the following warning:
この装置は､現在設置されている場所で妨害波の測定がされた情報技術装
置です。この場所以外で使用する場合は、その場所で、再び妨害波の測定が
必要となります｡
[Translation: This is a product for which interference was measured and confirmed to comply at the present installation site. When this equipment is used at any other location, interference must be measured at the new location for compliance.]478
472 Id. 473 EAMSL, Art. 10. See also PSE Guide at § 6. 474 The products are indoor installation-type instantaneous gas and bathtub water heaters, kerosene water and bathtub heaters, closed combustion-type kerosene heaters, built-in electric dishwashers, and electric driers for bathrooms, electric fans, air conditioners, ventilation fans, washing machines, and CRT televisions. See PSE Guide, § 6.3(1), pg. 65, nn. 16 & 17. 475 Id. at § 6.3(2). 476 VCCI Rules at Art. 10.1. 477 Id. at Art. 10.2. 478 Id. at Art. 10.3. -82-
Usage of the VCCI Mark must be done in accordance with the organization’s rules.479 Additionally, warnings for Class A equipment and equipment whose testing is limited to a particular place must be placed in instruction manuals.480 A warning statement is optional for Class B equipment instruction manuals. Confidentiality Procedures
TRC Certification
RCBs are required to ensure that information contained in applications submitted to RCBs will be treated with acceptable confidentiality protections.481
Terminal Equipment Approvals
There are no explicit confidentiality provisions in the Telecommunications Business Law for to benefit manufacturers.
PSE Certification
Applicants may maintain confidentiality regarding certain aspects of RF equipment subject to PSE Certification. However, the METI may require applicants to submit descriptions and summaries of information sought to be kept confidential.482
VCCI Certification
The VCCI will maintain confidentiality of applications if requested.483 Modifications of RF Equipment
TRC Certification
Modifications to certified RF equipment require manufacturers to obtain new certifications.484
Terminal Equipment Approvals
Manufacturers can be prohibited from using the MIC approved mark for a period of two years if their equipment is modified and no longer meets the applicable standards.485 Therefore, a new approval should be sought if equipment is modified. Manufacturers of Specified Terminal Equipment must notify MIC of any changes to the equipment or to their testing methods or results.486
479 Id. at Art. 10. 480 Id. at Art. 11. 481 Ordinance of MPT No. 37 of 1981, at Art. 10(8). 482 PSE Guide, § 5.2(1)(ii), pg. 58. 483 VCCI Rules at Art. 14. 484 See Terminal Equipment Overview, pg. 25. 485 Telecommunications Business Law at Art. 60(1)(iv). See also Terminal Equipment Overview, pg. 25. 486 Telecommunications Business Law at Art. 63(5). -83-
PSE Certification
Modifications to Specified Electrical Appliances and Materials may require the manufacturer to apply for a new PSE Certification. The certification applies to the product at the time it is imported into Japan.487 Therefore, if the product is subsequently modified a new certification would have to be obtained.
VCCI Certification
Modifications made to VCCI certified equipment require submission of a new VCCI Certification application.488 Market Surveillance
TRC Certification
MIC periodically purchases TRC certified equipment to examine their conformity with technical regulations, and will order the certificate holder to take corrective actions if necessary.489 MIC may also inspect manufacturers’ facilities or require them to report on their compliance with their certifications.490
Terminal Equipment Approvals
MIC conducts market surveillance and can request manufacturers to provide them with samples of terminal equipment.491 MIC will compensate manufacturers for providing equipment.492
PSE Certification
The METI periodically purchases PSE certified equipment, and tests them to ensure compliance with the EAMSL. If RF equipment is found not to comply with the law, the METI notifies the manufacturer to take corrective measures.493
VCCI Certification
487 PSE Guide, § 4.1(2), pg. 50. 488 VCCI Rules at Art. 8. 489 Yu Tanaka, Market Surveillance of Radio Equipment in Japan, Certification Promotion Office, Radio Department, Telecommunications Bureau, at www.tele.soumu.go.jp/resource/j/equ/mra/pdf/25/e_9- 3.pdf. 490 Radio Law at Arts. 38-20(1) and 38-21(1). 491 Telecommunications Business Law at Art. 167(1). See also Terminal Equipment Overview, pg. 23). 492 Telecommunications Business Law at Art. 167(2). 493 PSE Guide at § 1.2.1. -84-
VCCI routinely re-tests certified RF equipment, and will require manufacturers to modify the equipment should it fail to comply with VCCI technical specifications.494 Penalties for Non-Compliance
TRC Certification
MIC may suspend a certification for up to two years if it finds that RF equipment does not actually comply with its standards.495 Disregarding a suspension order can incur financial penalties up to ¥1 million, and imprisonment of 1 year.496 A maximum corporate fine of ¥100 million may also be applied.497 Failure to comply with a requested inspection or reporting requirement is punishable by a fine of ¥300,000.498
Terminal Equipment Approvals
MIC can require manufacturers to take steps to prevent harm to communications through telecommunications circuit facilities, such as modifying approved equipment that does not actually meet the requisite standards. 499 MIC can also remove approval of equipment where it deems necessary to protect communications through telecommunications circuit facilities.500 In such cases, MIC will issue a public notice stating that the equipment does not meet its standards and the equipment is viewed as not carrying the appropriate labels. 501 MIC can request reports from manufacturers and inspect their places of businesses and records to ensure that their terminal equipment is in compliance with its regulations.502
Manufacturers can be fined ¥500,000 for failing to obtain approval for terminal equipment.503 In regards to Specified Terminal Equipment, MIC can prohibit manufacturers from using the approval mark for a period of two years if they submit false notifications or whose equipment is found not to be compliance with MIC standards.504 MIC can also fine manufacturers for falsely self certifying their terminal equipment or failing to retain records concerning their testing of the equipment. 505 Manufacturers that fail to inform MIC of changes in their equipment can receive a non-criminal fine of ¥100,000.506
494 VCCI Rules at Art. 13 and Normative Annex 3. 495 Radio Law, Art. 38-28. 496 See MIC, Conformity Certification System for Radio Equipment in Japan at www.tele.soumu.go.jp/resource/j/equ/mra/pdf/23/e01.pdf. 497 Id. 498 Id. 499 See Telecommunications Business Law at Art. 54. 500 Id. at Art. 55(1). 501 Id. at Art. 55(2). 502 Id. at Art. 166(2). 503 Id. at Art. 187(ii). 504 Id. at Art. 66(1). 505 Id. at Arts. 188(viii) and (ix). 506 Id. at Art. 192(i). -85-
Manufacturers that do not comply with an order from MIC to take measures to protect the communications network or that affixes the approval label to equipment in contravention of a MIC order can be imprisoned for one year or fined ¥1 Million.507
PSE Certification
METI may request manufacturers to provide documentation supporting their compliance with the EAMSL.508 METI may also inspect the manufacturing facilities and import offices509 or request samples of products510 to ensure compliance with the EAMSL requirements.
It is punishable by one year of imprisonment and/or a fine of ¥1 Million to use the PSE marks without authority or sell or use Electronic Appliances and Materials without the proper PSE marks.511 Failure to notify METI that a notifying supplier is manufacturing or importing Electrical Appliances and Materials; failure to test Electrical Appliances and Materials and failure to maintain records of tests and certifications are punishable by a ¥300,000 fine.512
VCCI Certification
The VCCI Council will request that members modify the equipment in question if it is found to be out of compliance with VCCI standards.513 Failure to remedy VCCI Certification violations may result in the suspension of a product’s certification. Mutual Recognition Agreements
Japan has signed a mutual recognition agreement with the United States regarding the conformity of testing telecommunications terminal equipment and RF equipment. 514 The National Institute of Standards and Technology (NIST) accredits laboratories that will be accepted by Japan as Conformity Assistance Bodies (CABs).515 Pursuant to separate letter agreements, the US and Japan have agreed to the acceptance of test data for Electromagnetic Compatibility (EMC) for Information Technology (IT) Equipment.516 Under the letter agreements, the VCCI will accept test results from accredited US laboratories.517
507 Id. at Art. 181. 508 See EAMSL at Art. 45. 509 Id. at Art. 46(1). 510 Id. at Art. 46.2 511 Id. at Art. 57(i-iv). 512 Id. at Art. 58(i-iii). 513 See VCCI Rules at Art. 13. 514 See Agreement on Mutual Recognition of Results of Conformity Assessment Procedures between the United States of America and Japan (2007) (“Japan-US MRA”). 515 See Japan-US MRA, Annex, §II. See also Criteria for Designation of U.S. Conformity Assessment Bodies under the US-Japan Mutual Recognition Agreement (October 1, 2012 (Version 2.0)). 516 See Letter, dated February 16, 2007, from United State Trade Representative (USTR) to Embassy of Japan (USTR Letter) and Letter, dated February 26, 2007, from Embassy of Japan to USTR. 517 See USTR Letter, § 1(d). -86-
NEW ZEALAND
RF Equipment Laws/Regulatory Agency
The Radiocommunications Act of 1989 (“Act”)518 authorizes the Radio Spectrum Management (“RSM”), a business unit of the Ministry of Business, Innovation and Employment (“MBIE”) to regulate the sale and importation of radiofrequency (“RF”) equipment within New Zealand. RF equipment regulations are contained in the New Zealand Radiocommunications Regulations (“Regulations”).519 Codes of practice, rule updates, and other requirements respecting RF equipment are published as Radiocommunications Notices and Codes of Practice in the New Zealand Gazette (“Gazette”)520 Responsible Parties
RF equipment “suppliers” are responsible for ensuring that RF devices under their control comply with the applicable rules. Suppliers include: (a) New Zealand manufacturers that make RF equipment for marketing in New Zealand; (b) importers of RF equipment intended for marketing in New Zealand; (c) retailers or traders; and (d) authorized agents which are residents of New Zealand, acting on behalf of other suppliers in New Zealand.521 The appropriate supplier will, as described below, register as the party responsible for regulatory compliance of a given RF device. Suppliers of radio transmitting equipment in New Zealand (but not other types of RF equipment), must obtain a license from RSM to supply that equipment.522 Equipment Subject to Laws/Regulations
Two broad categories of RF equipment are subject to regulation in New Zealand: (1) Radio Products (“RP”); and (2) Electrical & Electronic Products (“EE&P”).523 RPs are intentional radiators that generate radio waves for various purposes and transmit radio waves for communications. 524 EE&Ps are unintentional radiators that generate energy for use within the devices, but do not transmit RF energy.525
Radio Products
RPs are divided into three “risk levels,” each of which has specific compliance requirements.
518 Radiocommunications Act 1989, No. 148 (Reprint December 5, 2013). 519 Radiocommunications Regulations 2001 (Reprint February 2, 2015). 520 Id. ¶ 32. 521 See Gazette, (August 8, 2015) (“Aug. 8 Gazette”) at ¶ 2. 522 Regulations ¶ 16. 523 Id.; Gazette (August 13, 2015) (“Aug. 13 Gazette”); Gazette (February 12, 2015) (“Feb. 12 Gazette”). 524 See Feb. 12 Gazette, Table 1. 525 See Aug. 13 Gazette, ¶¶ 4-9. -87-
A1 – Low Risk
Low risk devices include products such as Low Power FM transmitters, garage door openers, baby monitors, wireless-enabled devices, radio-controlled toys, and other various Short Range Devices (“SRD”).526
Supplier compliance requirements:
Provide product description;
Prepare a Declaration of Conformity (“DoC”);527 and
Properly label the device.528
A2 – Medium Risk
Medium risk devices include products such as cordless telephones and AM/FM telemetry equipment.529
Supplier compliance requirements:
Obtain a test report (or other reasonable documentation confirming compliance with applicable standard);
Prepare a DoC; and
Properly label the device.530
A3 – High Risk
High risk equipment in includes devices such as land mobile base stations, mobile radios, station, pagers, CB radio equipment, and VHF international maritime mobile equipment.531
Supplier compliance requirements:
Obtain a test report from an accredited testing body, confirming compliance with the applicable standard;
Provide a product description;
Prepare a DoC; and
Properly label the device.532
526 See Feb. 12 Gazette, Table 1. 527 The DoC requirements are described below. 528 Gazette (January 17, 2013) (“Jan. 13 Gazette”) at ¶ 4. 529 See Feb. 12 Gazette, Table 1. 530 Jan. 13 Gazette at ¶ 4. 531 See Radiocommunications Devices (Compliance Labelling) Notice 2003, as amended (March 1, 2013) at ¶ 4. 532 Jan. 13 Gazette at ¶ 4. -88-
Electrical and Electronic Products
Similar to RPs, EE&Ps are divided into three “risk levels,” each of which has specific compliance requirements.
L1 – Low Risk
Low risk equipment includes resistive heating elements, manually operated switches & simple relays, light bulbs, and wire-wound, mains frequency transformers.533
Supplier compliance requirements:
If the device is not a radio transmitter, supplier must ensure that the device meets the applicable standard and may label the product – if product is labeled, provide a product description and prepare a DoC.
If device is a radio transmitter, supplier must provide a product description, prepare a DoC, and properly label the device.534
L2 – Medium Risk
Medium risk equipment includes PCs, components, TVs, DVD players, and household appliances.535
Supplier compliance requirements:
Obtain a test report (or other reasonable documentation confirming compliance with applicable standard);
Provide a product description;
Prepare a DoC; and
Properly label the device.536
L3 – High Risk
High risk devices include industrial, scientific, and medical (ISM) equipment.537
Supplier compliance requirements:
Obtain a test report from an accredited testing body, confirming compliance with the applicable standard;
Provide a product description;
Prepare a DoC; and
533 Aug. 13 Gazette, ¶ 6. 534 Jan. 13 Gazette at ¶ 4. 535 Aug. 13 Gazette at ¶ 6. 536 Jan. 13 Gazette at ¶ 4. 537 Aug. 13 Gazette at ¶ 8. -89-
Properly label the device.538 Authorization Procedures
There are several steps in the compliance process for RF equipment suppliers in New Zealand.
License Requirement for Suppliers of Transmitting Equipment
Suppliers of radio transmitting equipment must obtain a license. An application must be submitted online through RSM’s website.539 The application is free, and RSM strives to process all license applications within one working day.540
Register as the Responsible Supplier
The supplier who agrees to be responsible for the regulatory compliance for a given device must register on the Electrical Regulatory Authorities Council (“ERAC”) website.541 The application is free and the process is quick and simple.542 Upon registering, the supplier will receive a supplier code number, which will be included in the DoC (described below).
Ensure Product Meets Appropriate Standard
Product standards for RPs and EE&Ps are listed in the Gazette,543 and can be obtained from Standards New Zealand.544 The supplier must accurately determine a device’s classification and risk factor, choose the correct standard for the devices, and provide evidence of compliance with the applicable standard.
Product Testing
Most RF devices (except for low-risk devices) require test reports as part of the authorization documentation. High risk devices require test reports from accredited testing bodies. As a practical matter and out of an abundance of caution, most suppliers opt to have their devices tested by an accredited testing body, regardless of the risk level of the device. An accredited testing body is a testing facility that is: (a) accredited by International Accreditation New Zealand (“IANZ”);545 (b) accredited by an accreditation authority that has entered into a mutual recognition arrangement with IANZ; or (c) approved pursuant to an agreement between New Zealand and any other countries, as published in the Gazette.546
Once the product is tested and approved as compliant with the applicable standard, the supplier must retain the report from the testing body for the period of time commencing with the product’s
538 Jan. 13 Gazette at ¶ 4. 539 https://www.rsm.govt.nz/online-services-resources/supplier-forms/application-for-licence-to-supply- radio-transmitters-organisation. 540 Id. 541 https://equipment.erac.gov.au/Registration/. 542 Id. 543 See, e.g., Feb. 12 Gazette, Table 1; Aug. 13 Gazette, Table 1. 544 http://www.standards.co.nz/. 545 Lists of accredited testing bodies can be found on the IANZ website: http://www.ianz.govt.nz/. 546 See Aug. 8 Gazette at ¶ 2. -90- introduction to the New Zealand market until five years after the product is no longer sold in New Zealand. The test report must consist of: (a) text, drawings, diagrams and tables specifying the standard to which the product was tested; (b) testing procedure; (c) measurement results; and (d) statement whether product conforms to the applicable standard. The test report must be in English and include any variants of the product.547
Prepare a Product Description
A product description is a universal authorization requirement. The supplier must prepare a description of the RF equipment that is sufficient for a person to determine that the equipment is the same as that for which the DoC (described below) was prepared. This means, at a minimum, the product description must identify its use, brand name, and model number. A photo and technical description can also be supplied.548
Prepare a Declaration of Conformity
A DoC is the document signed by the supplier, certifying that the RF device complies with the applicable standard. The DoC must contain the following information:
supplier’s name;
supplier’ New Zealand contact information (address, fax, and email);
supplier’s New Zealand Company Number;
supplier’s code number; and
product details, including (as applicable): (a) brand name; (b) model, lot, batch, or serial number; (c) description and function; (d) applicable standard (title, number, and edition); (e) test report; (f) (for transmitters) transmission power and frequency range; (g) declaration – “I hereby declare that the product to which this declaration of conformity relates complies with the aforementioned standard and all products supplied under this declaration will be identical to the sample identified in this declaration”; (h) name of supplier and nature of authority to make the declaration; and (i) date of declaration.549
Create a Compliance Folder
The compliance folder consists of the documents assembled by the supplier to support the compliance declaration: (a) product description; (b) DoC; and (c) test report (or, if applicable, other documented evidence of conformity).550 Labeling Requirements
There are two different types of labels for RF devices in New Zealand.
547 See Jan. 17 Gazette at ¶ 5. 548 See Aug. 8 Gazette at ¶ 2. 549 See Aug. 8 Gazette at ¶ 8. 550 Id. at ¶ 6. -91-
For Radio Products marketed under levels of conformity A1, A2 and A3, the R-NZ label should be used. This label contains the characters “R-NZ” and the New Zealand supplier code number.551
For other RF devices, the RCM label must be used: 552
The label must be legibly and durably applied on an external surface of the product. The label must be no smaller than 3mm in height for the compliance mark or the characters R-NZ and 1mm in height for the supplier identification.553
Products may be electronically labelled by means of an integral display providing: (a) the documentation that accompanies the product when it is supplied to the user sets out the method for displaying the compliance label; and (b) the compliance label is applied to the product in a way that would make it difficult to delete, modify, or prevent the display of the label.554 Fees
No fees are required to be paid to RSM regarding RF equipment authorization. Exception to Authorization Requirements
There are certain RF devices exempt from authorization and labeling requirements. These devices, however, must still comply with applicable standards:
Short range device (“SRD”) radio transmitters installed in vehicles when manufactured.
New Zealand Defense Force’s military radio transmitters.
Military radio transmitters of the defense force of another country operating in co- operation with the New Zealand Defense Force.555
For trade shows, the device must comply with frequency and output requirements in order to be demonstrated. Labeling will not be required for the duration of the show, provided that no devices are sold during this period. Confidentiality Procedures
RSM operates with the understanding that suppliers will have registered their intellectual property rights on the Intellectual Property Register, which while protected, will be publicly available. However, RSM will only release information that is relevant to the public register. Relevant information would only include: the product’s operating frequency, power output, purpose, and the standard to which it will be held to.
551 Id. at ¶ 2. 552 Id. 553 Id. at ¶ 6. 554 Id. 555 See Feb. 12 Gazette at ¶ 3. -92-
Penalties for Non-Compliance
The New Zealand RF equipment compliance framework aligns with the international trend away from hands-on regulatory type-approval and towards industry self-regulation. To maintain the integrity of the framework, RSM conducts routine "spot-check" auditing. Penalties for non-conformity or misrepresentation include:
Summary conviction fines (up to $200,000).
Daily conviction fines (up to $1,000 per day).
Infringement offenses (instant fines between $200 - $1,700)
Prohibition on the sale, importation, and manufacture of certain products.
Compulsory recall of certain products.556
556 Radiocommunications Regulations 2001, Regulations 34 -37 -93-
RUSSIA
RF Equipment Laws
Many regulatory provisions concerning Russian telecommunications and radiofrequency (“RF”) equipment safety and authorization are contained in Federal Laws, e.g. “About Communication”557 and “On Technical Regulation.”558 Additional regulations are found in Eurasian Economic Union Customs Union (“CU”) Resolutions.559 Regulated RF Equipment Types
Virtually all types of RF equipment are subject to regulation in Russia. For regulatory purposes, there are three broad categories of RF equipment:
Telecommunications Equipment (“TE”). Any type of RF device that connects with Russia’s Common Telecom Network (“CTC”) via wire, wireless or fiber interface. This includes wireless handsets, landline phones, cable equipment, fax machines, satellite systems, routers, broadcast transmitters, billing systems, wireless access equipment, modems, power supplies, batteries, optic cords, and any kind of service equipment.
Information Technology Equipment (“ITE”). Any RF device with a microprocessor that has no telecommunications or radio interface with the CTC. This includes products such as computer printers and monitors, as well as many types of local area network (LAN) equipment.
Wireless & Radio Equipment (“W&RE”). Devices with radio transmitters, including wireless handsets, Wi-Fi devices, RFID equipment, Bluetooth devices and many others. Some W&RE devices interface with CTC via radio, and hence are subject to the regulation as TE as well as W&RE. 560 Regulatory Agencies
A number of federal and regional agencies are involved in regulating RF equipment that is manufactured, imported, or marketed in Russia.
Federal Communications Agency (“Rossvyaz”)
Rossvyaz is responsible for type approval of telecommunications equipment (“TE”). Manufacturers of TE are required obtain authorization by Rossvyaz prior to marketing or importing their products in Russia. There are two types of Rossvyaz authorizations: Certification and Declaration of Conformity
557 Federal Law of the Russian Federation About Communication, No. 126-FZ (July 7, 2003) (as amended July 13, 2015). 558 Federal Law of the Russian Federation on Technical Regulation, No. 184-FZ (Dec. 18, 2002) (as amended July 13, 2015). 559 See e.g., Decision of the Commission of Custom Union “About the Single list of products concerning which mandatory requirements within the Customs union are established” No. 526 (Jan. 28, 2011) (“CUCR No. 526”). 560 See http://eng.rossvyaz.ru./activity/correlation/Certificates_list/(“Rossvyaz Website”); www.gost-r.info/ (“Gost R Website”). -94-
(“DoC”). 561 Certification is required for many types of TE that perform the following functions: switching and routing, digital transmission, billing & accounting, control & monitoring, radio and television broadcasting; and operative-search retrieval.562 DoC is required for all other types of TE.
Eurasian Economic Union Customs Union (“CU”)
The CU encompasses Russia, Belarus and Kazakhstan. The CU Technical Regulations (“TR-CU”) require that RF equipment marketed in any of these three countries be tested and certified that it meets certain electromagnetic compatibility (“EMC”) and product safety standards.563 For most RF products, including “means of telecommunication” as well as low voltage and high voltage devices, a certification is required.564
Federal Security Service (“FSB”)
Manufacturers that import RF devices containing encryption technology, as well as mobile telecommunications equipment, radios, and devices used for digital signature into Russia must file notification with the FSB before importing the devices into any of the CU countries.565
Ministry of Industry and Trade of the Russian Federation (“Minpromtorg”)
Minpromtorg is an executive agency that drafts and implements regulations affecting many industries, including technology. Minpromtorg also regulates imports and exports in the CU countries. Suppliers of most types of RF devices will need to obtain a Minpromtorg license prior to importing their products in Russia.566 There are three types of Minpromtorg licenses: (1) One-Time License, which concerns the importing or manufacturing of a number of goods and certain types of manufacturing; (2) Exclusive License, which authorizes the exclusive importing of certain goods; and (3) General License, which gives the right to import a specific type and quantity of goods.567 Responsible Parties
Manufacturers, importers and/or marketers of RF Equipment are responsible for obtaining the necessary authorizations, are responsible for ensuring that the RF Equipment under their control remains in compliance with Russia’s myriad of regulations.568 Most of the required applications must be signed and filed by in-country agents.569
561 See No. 126-FZ, Art. 43. 562 See About Communications at Art. 41; “About approval of the list of the means of communication which are subject to obligatory certification” RF Order No. 532 (June 25, 2009). 563 See CUCR No. 526 at 1. 564 Id. at 3. 565 See http://progost.com/other-doc/fsb-notification/ (“FSB Note Website”). 566 See http://www.en.gost24.com/russian-notification-of-the-fsb.php (“Gost R Notification Website”) 567 Id. 568 See About Communications at Art. 41; http://eng.customs.ru/ (“Customs Website”). 569 See “Russian Legislation Concerning the Technical Regulations of Information and Communications Equipment,” Federal Communications Agency (June 20, 2006) at 21. -95-
Testing and Authorization Procedures
Rossvyaz Authorizations
Certification
The general procedure for obtaining a Rossvyaz Certification is as follows:
File Application. Application (containing the requisite corporate and technical information and device samples) is filed with an agency-approved certification body, which performs a preliminary analysis to determine whether the equipment is suitable for operations in Russia. If the application is approved, the certification body will notify the applicant, which will execute an “agreement” with the certification body.
Testing. Once an agreement is reached between the two parties, the applicant submits the device to an authorized laboratory for testing to ensure compliance with the applicable technical specifications. If the device passes the test, the lab will send the test results and approval to the certification body.
Certificate Issuance. The certification body sends a copy of the approval certificate to Rossvyaz, which registers the certificate and sends it back to the certification body, which in turn sends it to the applicant. If the testing results demonstrate that the RF Equipment complies with Russian technical requirements, then the Rossvyaz Certificate will be issued to the applicant.570
DoC
The streamlined DoC process involves a relatively simple procedure:
Testing. The applicant negotiates an agreement with an approved testing lab, and submits the device =for testing. The lab sends the test report back to the applicant.
Declaration. If the device passes the test, the applicant prepares a DoC and sends it to Rossvyaz, which registers the DoC and sends same back to applicant.571
Lead time for a certification is typically three to four months, whereas a DoC can often be procured within one month. Certificates & DoCs are issued for up to three years, after which they must be renewed annually.572
TR-CU Certification
Testing. Negotiate agreement with an approved testing facility, and submit the device to same for testing to ensure compliance with applicable EMC and other standards.
Application. Submit application to the CU authority, including the following items:
o The Rossvyaz Certificate and Test Report;
570 See www.niicc.ru/uploads/s3_presentation_testcentre_eng (“ICC Website”). 571 Id. 572 See http://customsunioncertificate.com/customs-union-certificate/ (“EAC Website). -96-
o EMC Test Report;
o User’s Manual and Instructions (in Russian);
o Label Drawing (with certification body code);
o Factory ISO Certificates;
o TR-CU Authorized Factory Inspection Report; and
o Ergonomic Test Report/ Certification (for displays).
Approval. If the application is approved, the certificate will be registered and send to the applicant by the CU authority. 573
The certificate is valid for a period of 1-5 years as chosen by the manufacturer. After the initial term, the certificate must be renewed annually for so long as the product is offered for sale in Russia. Lead time for a certificate is typically several months.574
FSB Notification
The FSB notification is a rather complex document that requires detailed technical information about the product at issue. Applicable certifications must be included in the notification.575
Minpromtorg License
Applying for a Minpromtorg License is very complex and involves coordination among authorities in all three CU member states. This process often involves the filing of several applications and supplying the authorities with extensive documentation. Accordingly, lead time for a Minpromtorg license can be substantial. Licenses typically expire after one year.576 Application Fees
The application fees for all the authorizations vary widely depending on the specific product. Labeling Requirements
The only labeling requirement for RF devices in Russia is a TR-CU Mark:
The size of the mark should be not less than 5 millimeters, and should be visible to the naked eye for the lifetime of the product.577
573 See “Russia Certifications for Radio Devices,” SIEMIC, Inc. (2012). 574 Id. 575 See www.en.gost24.com/russian-notification-of-the-fsb.php. 576 Id. 577 See EAC Website. -97-
Confidentiality
Applicants seeking confidentiality protections for their certification applications should inquire with the various Russian certification bodies to determine whether their applications may be granted such treatment. Modifications to RF Equipment
Any changes made to a certified product are deemed to be non-compliant by the Russian authorities.578 Accordingly, each certification body maintains unique modification policies regarding their certifications. Certificate holders should check with the proper certification body to determine the policies applicable to RF Equipment devices. Market Surveillance
Certification compliance enforcement is conducted by the Russian Federal Police who regularly conduct market surveillance to determine whether a certified product is being retailed in compliance with the relevant rules and regulations.579 Penalties for Non-Compliance
Russian laws provide for fines and criminal penalties for non-compliance with product certification guidelines. Criminal charges may be filed in cases where non-compliance resulted from safety violations, or fraud. Additionally, charges against local company representatives and officers may be brought, and company assets may be seized and forfeited to pay off civil penalties.580
578 See About Communication at Art. 41. 579 http://incompliancemag.com/article/compliance-in-brazil-russia-india-and-china-for-information- technology-equipment/. 580 Id. -98-
SOUTH AFRICA
RF Equipment Laws/Regulatory Agency
The Electronic Communications Act (“Act”)581 and the Regulations for the Type Approval of Equipment (“Type Approval Regulations”)582 contain the regulatory laws and policies concerning radiofrequency (“RF”) devices in South Africa. RF equipment that is manufactured, imported, or marketed within South Africa is subject to testing, authorization, and labeling requirements. The Independent Communications Authority of South Africa (“ICASA”) is the regulatory authority that oversees the RF equipment testing and authorization process.583 Responsible Parties
“Suppliers” are responsible for ensuring that all RF equipment (as described below) deployed in the South African marketplace has been properly granted type approval from ICASA, and that the equipment continues to meet the applicable standards and regulations during the entire product life- cycle.584 Suppliers are South African manufacturers, importers, distributors, or citizens registered with ICASA for type approval.585
Type approval is the process by which RF equipment is authorized by ICASA. Type approval involves verification of the equipment’s compliance with applicable standards and other regulatory requirements.586
As noted above, responsible suppliers must register with ICASA’s supplier database.587 In order to register, applicants must first register as a South African entity with the Companies and Intellectual Property Commission (“CIPC”).588
The responsible supplier must to obtain type approval for the subject equipment prior to introducing it to the South African market. ICASA also requires that each subsequent party in the supply chain assume responsible for ensuring that it retains a copy of the type approval certificate respecting the RF equipment it imports or markets, and that the equipment bears the appropriate label (as described below).589 Suppliers are also responsible for updating the ICASA supplier database concerning details of relevant corporate changes within 30 days of the change.
581 Electronic Communications Act No. 36 of 2005 (as amended by Electronic Communications Act 1 of 2014). 582 See ICASA Type Approval Regulations South Africa Government Gazette No. 36785 (August 26, 2013) (“Type Approval Regulations”). 583 See Independent Communications Authority of South Africa Act 13 of 2000 (“ICASA Act”) at Chapter 2. 584 See Type Approval Regulations at 8. 585 Id. at 5. 586 Id. at 6. 587 Id. at 8. 588 Id. 589 See “Reasons Document in Respect of Type Approval Regulations, 2013 and Labelling Regulations,” 2013, Government Gazette No. 36791 (August 26, 2013) at 8. -99-
Regulated RF Equipment Types
Regulated RF equipment is divided into three categories:
Radio Equipment is defined as transmission equipment and related component. This type of equipment may be used in a fixed, mobile or portable application.
Telecommunication Equipment means equipment connected to and used within South Africa’s public telecommunication network, including telecommunication terminal equipment and may be powered by the telecommunication network.
Telecommunication Terminal Equipment (“TTE”) means end-user or service provider equipment (or a significant part of that equipment), which enables communication and is connected, directly or indirectly, by any means to interfaces of the public telecommunication network.590 Testing and Authorization Procedures
ICASA has adopted three type approval application procedures: (1) Standard Type Approval; (2) Simplified Type Approval; and (3) Provisional Type Approval.591 Most applicants will be subject to the Standard Type Approval guidelines, unless they meet the requirements for one of the other two approval types. An applicant can follow the Simplified Type Approval guidelines if the equipment is identical to equipment that has already been granted type approval, and the equipment appears on the Type Approval Register.592 An applicant can follow the Provisional Type Approval guidelines to obtain temporary Type Approval for the use of equipment for a trial, demonstration, or research purposes on a non-commercial basis.593
Standard Type Approval
An application for Standard Type Approval must include one of two application forms, depending on the type of equipment submitted for approval. Suppliers of Radio Equipment and Telecommunication Equipment must complete the Standard Type Approval Application for Radio Frequency (RF) Equipment for Use in South Africa.594 Suppliers of TTE must complete the Standard Type Approval Application for Telecommunications Terminal Equipment for Use in South Africa.595
Before submitting their applications to ICASA, applicants must have their devices tested by an Accredited Test Laboratory (“ATL”). An ATL includes any testing laboratory accredited within South Africa or by another country’s national accreditation body and/or other recognized accreditation body as per the ISO/IEC 17025 standard requirements.596
A completed type approval application must be accompanied by the following:
590 See Type Approval Regulations at 4-6. 591 Id. at 9-11. 592 The Type Approval Register is a government database that contains technical and compliance information on all RF equipment approved by ICASA. Id. at 7. 593 Id. at 10-11. 594 Id. at Schedule 2.1. 595 Id. at Schedule 2.2. 596 Id. at 4. -100-
test reports confirming compliance with the applicable standards
photographs of the equipment, installation, and user manual;
a functional description of the equipment;
schematic diagram, printed circuit board layout; and
proof of payment of the prescribed non-refundable Type Approval fee.597
ICASA may request the applicant to submit additional supporting documents, as necessary. If the application is approved, ICASA will issue a Type Approval Certificate. If rejected, ICASA will issue a letter containing the reasons for rejecting the application. The applicant may address the issues identified in the rejection letter and re-apply for Type Approval.598
Simplified Type Approval
As stated above, a supplier may follow the Simplified Type Approval procedures if it markets equipment that is identical to equipment that is already type approved and the approved equipment appears on the Type Approval Register.599
An application qualifying for Simplified Type Approval must include a completed application form. The required form is the “Simplified Type Approval Application for Radio (RF) Equipment and Telecommunication Terminal Equipment (TTE) for Use in South Africa.”600
The Simplified Type Approval process does not require the submission of test reports. However, ICASA may require the applicant to provide a representative sample of the equipment. If the application is approved, the ICASA will issue a Type Approval Certificate.601 If rejected, ICASA will issue a letter containing the reasons for the rejection. The Applicant may address the issues identified in the rejection letter and re-apply for Type Approval.602
Provisional Type Approval
Applicants may apply for provisional type approval for a period up to 6 months, for the use of equipment for a trial, demonstration or research purposes on a non-commercial basis.603
An applicant seeing Provisional Type Approval must complete a “Provisional Type Approval Application for Use in South Africa.”604
The Applicant must also submit the following information:
the purposes of the test, trial, research or demonstration;
597 Id. at 9. 598 Id. 599 Id. 600 Id. at Schedule 2.3. 601 Id. at 9. 602 Id. 603 Id. at 10. 604 Id. at Schedule 2.4. -101-
details of the units to be tested;
details of the proposed recipients of the units;
duration of the test, trial, research or demonstration;
the geographic areas where the test, trial, research or determination are to be performed; and
proof of payment of the applicable fee.605
The applicant must provide ICASA with a report of the test, trial, research or demonstration within 30 days from the end of the permit period.606 If the applicant chooses not to apply for type approval within or after the permit period, the applicant must ensure that all units are withdrawn at the applicant’s cost, within 30 days from the end of the permit period.607 Application Fees
ICASA charges the following Type Approval application fees:
TTE: R4000.00
Radio Equipment: R4000.00
Untested Variant: R2000.00
Tested Variant: R2000.00
Badge Engineering: R4000.00
Labels (packets of 400 units): R400.00
Provisional Type Approval: R2000.00608 Certification Application Processing Time
ICASA typically takes about 15 business days to process a type approval application. Incomplete applications will result in delays.609 Labeling Requirements
All type approved equipment must be compliant with ICASA’s labelling regulations as follows:610
a permanently affixed and legible label must be affixed to the equipment;
605 Id. at 11. 606 Id. 607 Id. 608 Id. at Schedule 1. As of the date of this writing, one South African Rand = 0.072 US Dollar. 609 “Guidelines Relating Type Approval Framework, Government Gazette” No. 36792 (August 27, 2013 (“Guidelines”) at 7. 610 Id. at 12. -102-
the packaging and container of the device must also bear a label;
the label must be affixed before the equipment is made available by sale or lease or is supplied in any manner;
where a permanently affixed label is not feasible, the supplier must submit a written request for an alternative method of displaying the label, prior to supply or use of the equipment;
the label must be protected against damage, such as scratching and ultraviolet exposure that may lead to the information on the label becoming illegible;
the label must include the following information: ICASA logo, and the ICASA issued certificate number(s);
the minimize size of the logo is 3 mm high and 3mm wide. The issued certificate number must be 1 mm high. 611
Printed labels may be obtained from ICASA.612 If a supplier prefers not to obtain labels from the ICASA, it must request in writing permission to print the ICASA label. The request must include a sample of the proposed label.613
The following is a sample of the format of the ICASA label:
TA XXXX-YYYY APPROVED
Confidentiality
Type Approval applicants may request that specific submitted information be treated as confidential. Any request for confidentiality must contain a written statement as to the subject information should be treated as confidential. When considering such a request, ICASA must, if the information is sufficiently detailed, treat the following types of information as confidential:
trade secrets;
financial, commercial, scientific or technical information, if the disclosure would harm the commercial or financial interests of the applicant;
611 “Labeling Regulations,” Government Gazette No. 36786 (August 26, 2013) at 5. 612 Id. at 7. 613 Id. -103-
information of which the disclosure could reasonably be expected to disadvantage the applicant in contractual or other negotiations or prejudice the applicant in commercial competition;
names of prospective employees; and
the applicant’s business plan. 614
No confidentiality is available for any information in the public domain or is required to be released by a court order.615
ICASA is required to render a decision on a request for confidentiality within 14 days of receipt. The decision must include the reasons for same. If ICASA does not grant confidentiality, the applicant must be given the opportunity to withdraw the information that is the subject of the confidentiality request.616 Modifications to RF Equipment
Type Approval Certificates are valid for an unlimited duration provided that no modifications are made with respect to the brand and/or equipment name, model, and function recorded on the Type Approval Certificate and/or Type Approval Register, and provided that no modifications are made to the technical specifications of the equipment.617
Any change to a certified RF device, with the exception of a cosmetic change (e.g., change in color, external design or enclosure) will be considered a modification, rendering the Type Approval Certificate invalid and requiring a new Type Approval Certification. These changes include, but are not limited to, alterations to the operating frequency band or RF power, brand or product name, model number, or any device function.618
If the standard under which Type Approval was obtained changes, the Type Approval may be rendered invalid.619 Market Surveillance
ICASA is authorized to conduct market surveillance on equipment that requires type approval in the following circumstances:
a consumer or other entity files a complaint; or
during a random ICASA compliance audit.620
614 See ICASA Act at §4D. 615 Id. 616 Id. 617 See Type Approval Regulations at 11-12. 618 Id. at 11. 619 Id. 620 Id. at 12. -104-
As part of its the market surveillance, ICASA may require the supplier to submit a sample of the subject equipment for a conformity assessment or conduct a visual examination of the equipment, label, packaging and Type Approval Certificate.621 Penalties for Non-Compliance
Any person that offers for sale or has in their possession with the intention to sell, any RF equipment that is not Type Approved is subject to imprisonment of 6 months and/or is liable to a fine not to exceed R 1,000,000 per violation.622 SOUTH KOREA
RF Equipment Laws/Regulatory Agencies
The Radio Waves Act623 regulates the radiofrequency (“RF”) equipment conformity assessment system in South Korea. This law established the South Korea Minister of Science, ICT and Future Planning (“MSIP”) as the regulatory agency that oversees the RF equipment registration and certification process in South Korea.624
The MSIP’s sub-agency, the National Radio and Research Agency (“RRA”)625 reviews the registration and certification applications, designates equipment testing institutions, and grants certifications to applicants whose RF devices are in compliance with the applicable standards and regulations.626 The RRA issues a Korea Certification Mark (“KC Mark”) to indicate compliance with the applicable regulations.627 Responsible Parties
Manufacturers, retailers, and importers of RF equipment imported or marketed in South Korea must comply with the RF certification or registration process.628 Regulated RF Equipment Types
All RF equipment sold and operated in South Korea must be tested and registered with the RRA.629 However, there are three separate testing processes that apply depending on the RF equipment type. The following summarizes the three certification processes:
Certification of Conformity630
621 Id. 622 Id. at 13-14. 623 Radio Waves Act, Ch. V, §1 (1961), as amended by Act No. 11712 (Mar. 23, 2013) (“Radio Waves Act”). 624 Id. 625 Introduction for Conformity Assessment System, NRRA. 626 Radio Waves Act at Ch. V, § 1. 627 Radio Waves Act at Art. 58-2(2), (3), (6). 628 Radio Waves Act at Art. 58-2(1). 629 Radio Waves Ac at Art. 58-2(1). 630 Referred to as “Suitability Certification” in Radio Waves Act. See Radio Waves Act at Art. 58-2(1). See also Introduction for conformity Assessment System, RRA (“Certification of Conformity”). -105-
The following RF equipment types are subject to the Certification of Conformity process: (1) those that are likely to cause harm to the radio wave environment or to broadcasting communications networks; (2) those that cause significant electromagnetic interference; or (3) equipment that is affected by electromagnetic waves to the extent that it does not function normally.631 Such devices include: wireless telephones, Internet modems, and radar systems.632
Registration of Compatibility633
RF equipment not subject to the Certification of Conformity requirements are generally subject to the Registration of Compatibility requirements – meaning that they do not produce harmful interference or other operational issues.634 Such devices include: computer devices and peripherals, broadcasting set-top boxes, and electronic measuring instruments.635
Interim Certificate of Conformity636
The Interim Certificate of Conformity is available for new RF devices that have not been sold and/or operated in South Korea, and do not produce any harmful interference or other operational issues.637 Testing and Authorization Procedures
The following summarizes the testing authorization procedures under the Certification of Conformity, Registration of Compatibility, and Interim Certification processes.
Certification of Conformity
The Certification of Conformity is a 4-step procedure as follows:
Device Testing – Applicant must first submit RF Equipment device to an MSIP-designated testing laboratory for testing.638 The scope of testing varies by the specific device,639 but generally includes the following testing types:640
o electromagnetic compatibility standards;641
631 Radio Waves Act, Art. 58-2(2). 632 National Radio and Research Agency (RRA), Public Notification on Conformity Assessment for Broadcasting and Communications Equipment, RRA Public Notification 2012-16 at Art. 3-1, Annex Table 1 (eff. Jan. 24, 2011) (“RRA Public Notification 2012-16”). 633 Referred to as “Suitability Registration” in Radio Waves Act. See Radio Waves Act at Art. 58-2(1). See also Introduction for Conformity Assessment System, RRA (“Registration of Compatibility”). 634 Radio Waves Act at Art. 58-2(3). 635 RRA Public Notification at Art. 3-2, Annex Tables 2, 3. 636 Referred to as “Provisional Certification” in Radio Waves Act. See Radio Waves Act at Art. 58-2(1). See also Introduction for conformity Assessment System, RRA (“Interim of Conformity”). 637 Radio Waves Act at Art. 58-2(7). 638 Id. at Art. 58-5. 639 See RRA Notification 2012-16 at Annex Table 1 (applied conformity assessment criteria). 640 RRA Notification 2012-16 at Art. 4. 641 See Radio Waves Act at Art. 47-3(1). -106-
o radio communication operational standards;642
o wire communication standards;643 and
o specific absorption rate (“SAR”) standards.644
Once testing is completed, the lab provides the applicant with a report of the test results.645
Submit Application for Certification of Conformity – The applicant must prepare and submit the following documents to the RRA Director General646:
o Certification Application Form (See RRA Notification 2012-16 at Annex Form 1);
o Conformity Assessment Identification Code Application Form (See RRA Notification at Annex Form 2)
o User’s Manual (must be in Korean);
o Testing Report;
o Front/ Rear-View Photographs of the Device;
o Part Arrangement Diagram/ Photograph;
o Circuit Diagram; and
o Letter of Representation/ Power of Attorney (See RRA Notification at Annex Form 4).
Once the application has been submitted, the RRA Director General will then commence its review.647
Certification Review by RRA Director General. The RRA Director General must review the following:
o Application and associated documents listed in Article 5(1) of the RRA Notification 2012-16;
o Compliance with technical standards listed in Article 4 of the RRA Notification 2012- 16; and
o Validity of the test report.648
642 See Radio Waves Act at Arts. 37, 45, 47-2; Broadcasting Act at Art. 79 (1987), as amended Act. No. 12093 (Aug. 13, 2013). 643 See Framework Act on Broadcasting and Communication Development at Art. 28 (2010), as amended Act No. 11373 (Feb. 22, 2012) (“Framework Act on Broadcasting and Communication Development”); Telecommunication Business Act at Art. 21, 28, 69 (1991), as amended Act No. 8867 (Feb. 29, 2008) (“Telecommunication Business Act”). 644 See Radio Waves Act, Art. 47-2. 645 See RRA Notification 2012-16 at Art. 5(3). 646 Id. at Art. 5(1). 647 Id. at Art. 6(1). 648 Id. -107-
Once the RRA Director General has completed a satisfactory examination of the application and testing results, a Certificate of Conformity may then be issued.649
Issuance of the Certificate of Conformity – Once the RRA Director General has completed its review, it must issue a Certificate of Conformity650 to the successful applicant, and release the following information in an official newsletter:
o Registrant Official/ Trade Name;
o Equipment Name/ Model Number;
o Certification Number;
o Type Identification;
o Manufacturer/ Country of Origin; and
o Date of Certification.651
Once the applicant receives its Certificate of Conformity, it must then ensure that the KC Mark is affixed to all certified-devices sold and/or operated in South Korea.652
Registration of Compatibility
The authorization process for RF Equipment devices subject to the Registration of Compatibility generally follows a 4-step process:
Testing. Applicants must first submit the RF Equipment device to an MSIP-designated laboratory for testing.653 The scope of testing varies by the specific device, 654 but generally includes the following testing types:655
o Electromagnetic Compatibility Standards;656
o Radio Communication/ Broadcasting Operational Standards;657
o Wire Communication Standards;658 and
o Specific Absorption Rate (SAR) Standards.659
649 RRA Notification 2012-16 at Art. 7. 650 Id. at Annex Form 3. 651 Id. at Art. 7. 652 See Radio Waves Act at Art. 58-2(6). 653 Id. at Art. 58-5. 654 See RRA Notification 2012-16 at Annex Table 1 (applied conformity assessment criteria). 655 Id. at Art. 4. 656 See Radio Waves Act at 47-3(1). 657 Id. at Art. 37, 45, 47-2; Broadcasting Act at Art. 79. 658 See Framework Act on Broadcasting and Communication Development at Art. 28; Telecommunication Business Act at Art. 21, 28, 69. 659 See Radio Waves Act at Art. 47-2. -108-
Once testing is completed, the testing laboratory releases a testing report to the applicant of the testing results.660
Application for Registration of Compatibility. The applicant must prepare and submit the following documents to the RRA Director General:
o Registration Application Form (See RRA Notification 2012-16 at Annex Form 5);
o Letter of Confirmation confirming conformity to the assessment criteria (See RRA Notification 2012-16 at Annex Form 6); and
o Letter of Representation/ Power of Attorney (See RRA Notification at Annex Form 4).661
Once the application has been submitted, the RRA Director General will then issue the registration of compatibility.662
Issuance of Registration of Compatibility – If the application materials are properly submitted, the RRA Director General must then issue a Registration of Compatibility to the applicant, and announce the following details in the RRA’s official newsletter:
o Registrant Name/ Trade Name;
o Equipment Name/ Model Number;
o Certification Number;
o Type Identification;
o Manufacturer/ Country of Origin; and
o Certification Date.663
Document Reporting to RRA – Once the applicant receives its Registration of Compatibility for its device, it must submit the following documents and information to the RRA Director General:
o Registration of Compatibility application and associated documents;
o User’s Manual;
o Testing Report;
o Front/ Rear Photographs of Device;
o Part Arrangement Diagram/ Photograph;
o Circuit Diagram;
660 See RRA Notification 2012-16 at Art. 5(3). 661 Id. 16 at Art. 8. 662 Id. at Art. 9. 663 Id. at Art. 9. -109-
o List of Series Models/ Documents Regarding Electrical Circuitry; Structure; and Additional Functions (Series Models only); and
o Documents verifying any modifications made to equipment.
Devices subject to Registration of Compatibility must comply with the labeling requirements found in Annex 5 of the RRA Notification 2012-16.
-110-
Interim Certificate of Conformity
The Interim Certificate of Conformity is a 4-step procedure as follows:
In-House Testing. Applicants must test their device subject to any relevant Korean and/or international standards for such devices. Testing results must be submitted to RRA Director General and/or an MSIP-designated testing agency for confirmation prior to submission of application for Interim of Conformity.664
Application for Interim Certificate of Conformity. Applicants must prepare and submit the following documents to the RRA Director General:
o Interim Certification of Conformity Application (See RRA Notification 2012-16 at Annex Form 8);
o Technical Manual (in Korean) including: (1) Korean and/or international standards of the relevant field; (2) a technical description, and a summary of technical methods (if Korean and/or international standards do not exist); and (3) documents that verify device is eligible for an Interim Certificate of Conformity (See Radio Waves Act at Art. 58-2(7)):
In-House Testing Report;
User’s Manual (in Korean);
Front/ Rear Photographs of Device;
Circuit Diagram;
Part Arrangement Diagram/ Photograph; and
Letter of Representation/ Power of Attorney (See RRA Notification at Annex Form 4).665
Once the application has been submitted, the RRA Director General will commence its review of the application and testing results.666 The following criteria are reviewed at this stage:
completeness/ content of application and related documents;
whether the equipment is eligible for an Interim Certificate of Conformity Act;
whether frequencies were appropriately distributed pursuant to Article 9 of the Radio Waves Act; and
whether the area of use or the applicant’s expiration period is appropriate.667
The review is subject to the following standards:
664 See Radio Waves Act at Art. 58-2(7); RRA Notification 2012-16 at Art. 11(1). 665 RRA Notification 2012-16 at Art. 11. 666 Id. at Art. 12. 667 Id. at Art. 12(2). -111-
International Standards Organizations (e.g., ITU, ISO/ IEC);
Korea Information Communication Standard and Korean Industrial Standards;
Broadcasting and communications-related standards;
Other internationally-accepted applicable standards; or
Standards proposed by the applicant in the case of an internationally new technology.668
Once the RRA Director General has completed its review, and if the RF equipment is in compliance it will issue an Interim Certificate of Conformity to the applicant.669 The following information will be published in an official newsletter:
Applicant’s Name/ Trade Name;
Equipment Name/ Model Number;
Certification Number;
Type Identification;
Manufacturer and Country of Origin;
Expiration Period; and
Other Operating Conditions.670
Confirmation of Customs Clearance
An importer of RF Equipment requiring customs clearance confirmation from the Head of the Customs Office671 must submit an application for issuance of conformity assessment confirmation (See RRA Notification 2012-16 at Annex Form 13), or a preclearance application to the RRA Director General.672 Upon receipt of either application type, the RRA Director General must confirm that the RF Equipment has cleared customs, and issue a confirmation notification.673 Application Fees
Application fees are listed in Article 97-2 of the Enforcement Decree of the Radio Waves Act.674 Certification Application Processing Time
After testing and application approved, the RRA will issue a certification after review within one day. Entire process takes roughly 2-3 weeks.675
668 Id. at Art. 12(3). 669 Id. at Art. 13(1). 670 Id. at Art. 13(1). 671 See Customs Act, Act. No. 6805, Art. 226(2) (2000), as amended Act No. 6777 (Dec. 18, 2002). 672 RRA Notification 2012-16 at Art. 28(1). 673 Id. at Art. 28(2). 674 Enforcement Decree of the Radio Waves Act, Pres. Decree No. 16158 at Art. 97-2 (Mar. 3, 1999). 675 See RRA Notification 2012-16 at Art. 26. -112-
Labeling Requirements
The KC Mark appears as follows:
All certified and/ or registered devices must display the KC Mark.676 Confidentiality
Confidentiality requests should be submitted to RRA, which will consider them on a case-by-case basis. Modifications to RF Equipment
Any changes to the technical specifications of certified device will void the current certification or registration of the device. Such modifications require the manufacturer to submit a Declaration of Changes to the RRA Director General, unless the modification is minor (e.g., replacement of resistor, inductor, capacitor, replacement of diode, and/or reduction of wattage without any circuit change).677 Market Surveillance
The RRA Director General may conduct market surveillance of certified and/or registered RF Equipment. If such devices are found to be non-compliant after testing, the RRA Director General will then issue a corrective order requiring manufacturers to ensure that deficient equipment is brought back into compliance. Failure to do so may result in fines and revocation of certification.678 Penalties for Non-Compliance
Fines and penalties can range between 3 million KRW (~ $ 2,584.62) and 100 million KRW (~ $ 86,154.00). Non-compliance may also result in the revocation of certification.679
676 See RRA Notification 2012-16 at Art. 23. 677 Radio Waves Act at Art. 58-2(5); RRA Notification 2012-16 at Art. 15-17. 678 RRA Notification 2012-16 at Art. 21-22; Radio Waves Act at Art. 58-4(1). 679 Radio Waves Act at Art. 58-4(1). -113-
TAIWAN (REPUBLIC OF CHINA)
RF Equipment Laws/Regulatory Agency
The Taiwan Telecommunications Act (“Act”)680 and accompanying regulations681 govern the country’s regulatory requirements regarding radiofrequency (“RF”) equipment. The National Communications Commission (“NCC”) (formerly the Directorate General of Telecommunications (“DGT”)) is Taiwan’s governing body respecting RF equipment.682 NCC oversees various RF equipment certification bodies (“RCBs”).683 With very limited exceptions, RF equipment may not be manufactured, imported, sold, or publicly displayed in Taiwan without proper authorization and labeling.684 Responsible Parties
The parties responsible for RF equipment regulatory compliance are manufacturers, importers, and distributors of RF Equipment in Taiwan.685 Regulated RF Equipment Types
Regulated RF equipment in Taiwan is divided into two broad categories: Controlled Telecommunications Radio Frequency Devices (“CTRFD”) and Telecommunications Terminal Equipment (“TTE”).686
CTRFD consists of self-contained “low-power” RF devices. CTRFD includes certain unintentional radiators, as well as many types of intentional radiators, e.g., tunnel radio systems, cable locating equipment, radio control devices, CB radios, and wireless microphones.687
TTE includes wireless telecommunications devices, wireline telephones, ISDN terminal equipment, radio terminal equipment, satellite personal communications equipment, and mobile earth stations.688
680 Taiwan Telecommunications Act (July 11, 2007). 681 See Compliance Approval Regulations on Controlled Telecommunications Radio-Frequency Devices (Dec. 29, 2014) (“RF Regulations”) and Compliance Approval Regulations of Telecommunications Terminal Equipment (Dec. 29, 2014) (“Terminal Regulations”). 682 Act at Art. 3. 683 See e.g., RF Regulations & Terminal Regulations at Art. 2. 684 Act at Arts. 42 & 49. 685 Id at Arts. 42 & 50. 686 Id. at Art. 2(1). 687 Id. at Art. 50; DGT Low-Power Radio-Frequency Devices Technical Regulations (Aug. 9, 2002) at 1-4, 17-22. 688 See Act at Art. 42, Terminal Regulations at Art. 2(1). -114-
Testing and Authorization Procedures
For RF equipment companies that wish to market their products in Taiwan, there are two types RF equipment authorization procedures from which an responsible party may choose: Type Approval and Declaration of Conformity (“DoC”).689
Type Approval and DoC
Type Approval and DoC are similar authorization procedures. Each requires device testing and an application to the RCB for authorization. The difference is that, with Type Approval, the RCB conducts an equipment conformity assessment and issues a compliance certificate to the Responsible Party.690 DoC, by contrast involves registering with RCB and declaring conformity with the applicable standards and technical requirements. The testing and application procedures for both methods of authorization are virtually identical.691 Type Approval is typically chosen by manufacturers who wish to export equipment to other countries that require certification by the country’s regulatory body.
Testing
Before submitting its application to the RCB, a Responsible Party must first submit a sample of its equipment to an RCC-recognized lab for testing to ensure that the device meets the appropriate standards and NCC’s technical specifications.692 If an NCC-recognized lab cannot test the subject equipment, the manufacturer can test the equipment itself or submit it for testing by a foreign testing lab, as long as report of the testing results (“test report) is in compliance with the applicable standards.693 Lead-time for testing is typically 2-4 weeks.
Application Requirements
To obtain compliance approval, applicants must complete and submit a “Sale Use” application form, and the following documents to an RCB (devices with different brand names or model numbers should be submitted separately):
An equipment sample (if required by the RCB);
One copy of Chinese or English operation manual or instructions;
One copy of Chinese or English technical specifications;
One copy of the electrical circuit diagram or the block diagram;
One copy of the test report;
One copy of the certificate of establishment for applicant’s Taiwan legal entity;
689 See RF Regulations & Terminal Regulations at Arts. 2-3. Taiwan also has authorization procedures for “private use” of RF equipment but devices authorized pursuant to that procedure are not permitted to be sold in Taiwan. Id. at Arts 7-8. 690 See CTRFD Regulations at Art. 7; Terminal Regulations at Art. 9. 691 Id. at Arts. 7-14 and 8-14 respectively. 692 Id. at Arts. 9,13 and 10, 12 respectively. 693 Id. Taiwan has signed mutual recognition agreements with Canada, Australia, Hong Kong, Singapore, and the United States regarding the testing of products abroad. -115-
A certificate of manufacturer or importer, if the application is being submitted by a distributor (manufacturers are exempt from this requirement);
Any other documents specified by the NCC; and
Five CDs that contain all of the above materials.694
Application Review Process
After submitting the application and accompanying materials, the RCB will commence the application review process. Assuming the application is complete, and testing results are accurate, the RCB will grant the application and issue a certificate or DoC, typically within two weeks.695 If the application is incomplete, the applicant will have one month after being notified to correct the deficiency. If the application is denied, the applicant will have two months to submit a new application.696
Post-Certification Procedures
Following issue of the certification or DoC, the Responsible Party of CTRFD must retain the approved sample equipment for the entirety of the time the equipment is sold in Taiwan, and five years after the removal of the equipment from the Taiwanese marketplace.697 Certificates and DoCs have no time limitation. Application Fees
Compliance approval fees must be submitted with the application to the ARCB. Approval fees are charged according to the fee schedule stipulated by the Ministry of Transportation and Communications (“MOTC”), which change frequently.698 The MOTC fee schedule should be consulted when an application is ready to be submitted. If the application is denied, fees are non-refundable. 699 Labeling Requirements
The Responsible Party must label all authorized equipment with a label of the type provided by the RCB with the certification or DoC. 700 Each label must be affixed or embossed directly on the equipment.701
694 Id. at Arts 10, 13 and 10, 12 respectively. 695 Id. The regulations do not list the application processing time, but the “unofficial industry norms” are 1- 2 weeks from application submission to decision. 696 Id. at Arts. 11 and 13 respectively. 697 See CTRFD Regulations at Art. 12. The Terminal Regulations do not list a similar requirement for TTE. 698 See CTRFD & Terminal Regulations at Arts. 22-23. 699 Id. 700 Id. at Art. 15. 701 Id. at Arts. 15-16. -116-
Modifications of RF Equipment
If RF equipment is modified by changing the brand name, model number, design, or RF function, it must be resubmitted for re-authorization. Changes in appearance and other minor modifications of a device do not require re-authorization.702 Market Surveillance
The RCB performs market surveillance activities on approved equipment. Equipment authorization may be revoked if any data/information attached to application package is found to be counterfeit or false.703 Penalties for Non-Compliance
Responsible Parties that violate Taiwan’s equipment authorization, importation and marketing rules are subject to substantial financial penalties and/or equipment confiscation and loss of authorization.704
702 Id. at Art 17. 703 Id. at Arts. 19-20. 704 See Act at Arts. 56-68. -117-
CONCLUSION
Each nation’s RF equipment rules are varied and complex. The overview presented in this Guide, based on salient research of current regulations, delineates the basic requirements for authorization, marketing and operation of RF equipment, as well as a summary of post-compliance practices to avoid penalty. Nevertheless, due to the ever-changing regulations and the sheer complexity of all the applicable rules, a comprehensive Guide covering all the possible RF equipment marketing, operation, and authorization scenarios is likely impractical. There are many other legal and regulatory issues that could apply when preparing to market a product, such as importation and exportation, vendor contracts, taxes, and recent rulemaking and enforcement proceedings.
Accordingly, it is critical that any company, seeking to market RF equipment internationally, enlist knowledgeable counsel to assist with the authorization process and the creation of a compliance plan. In addition, for companies already subject to enforcement proceedings, it is strongly advised that competent counsel be retained for representation. Self-representation will almost certainly result in the worst possible outcome; damaging both a company’s bottom line and business reputation.
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