Market Brief (Rubber Medical Devices) August 2015

MALAYSIAN RUBBER EXPORT PROMOTION COUNCIL

MARKET BRIEF (RUBBER MEDICAL DEVICES)

AUGUST 2015

UNITED STATES OF AMERICA

CONTENTS

Item Topic Page

1. COUNTRY PROFILE 2

2. MARKET SCENARIO 3

3. TRADE STATISTICS 5

4. IMPORT REGULATIONS 12

5. TARIFF & NON TARIFF BARRIERS 13

6. FREE TRADE AGREEENT (FTA) 14

7 TRANS PACIFIC PARTNERSHIP 14

8. MAJOR MEDICAL DEVICES SUPPLIERS IN USA 15

9. USEFUL CONTACTS 16

10. TRADE FAIRS 18

1.0 COUNTRY PROFILE

UNITED STATES OF AMERICA Capital: Washington D.C,

Population: 317.6 million (UN, 2010)

Area: 9.8 million sq km

Official language: English

Major religions: Christianity

Life expectancy: 76 years (men), 81 years (women)

Currency: US Dollar

Main exports: Computers and electrical machinery, vehicles, chemical products, food and live animals, military equipment and aircraft

Main imports: Agricultural products, industrial supplies (crude oil), capital goods (computers, telecommunications equipment, motor vehicle parts, office machines, electric power machinery), consumer goods (automobiles, clothing, medicines, furniture and toys).

GDP per capita: $54,800 (2014 est.)

GDP growth: 2.4% (2014 est.)

International dialing code: +1

2.0 MARKET SCENARIO

Health Care Industry in USA

Health care in the United States is provided by many distinct organizations. Health care facilities are largely owned and operated by private sector businesses. 58% of US community hospitals are non-profit, 21% are government owned, and 21% are for-profit. According to the World Health Organization (WHO), the United States spent more on health care per capita ($8,608), and more on health care as percentage of its GDP (17.2%), than any other nation in 2011. In the U.S., ownership of the health care system is mainly in private hands, though federal, state, county and city governments also own certain facilities.

The non-profit hospitals share of total hospital capacity has remained relatively stable (about 70%) for decades. There are also privately owned for-profit hospitals as well as government hospitals in some locations, mainly owned by county and city governments. The Hill-Burton Act was passed in 1946, which provided federal funding for hospitals in exchange for treating poor patients.

There is no nationwide system of government-owned medical facilities open to the general public but there are local government-owned medical facilities open to the general public. The U.S. Department of Defense operates field hospitals as well as permanent hospitals via the Military Health System to provide military- funded care to active military personnel.

Glove Demand in USA

The market for disposable medical gloves will be worth $4 billion by 2017, according to projections from a report published by Global Industry Analysts (GIA). The report cites rising emphasis on health, occupational safety and hygiene among health care workers as factors responsible for growth.

Gloves are essential in medical environments, especially in the operating room. Dozens of pairs are used in a single surgical case and with the number of surgical procedures performed in the U.S. and across the globe rising, it makes sense that the gloves market is due for sustained growth.

The U.S. is still the largest market for gloves, though Asian markets are the fastest growing, according to the GIA report. The Asian medical glove industry, long known for its production of natural rubber latex, an abundant natural resource in many Asian countries, is beginning to witness major changes. With growing demand for powder-free and synthetic gloves in domestic and foreign markets, Asian manufacturers are beginning to diversify their product portfolio to incorporate powder-free and latex-free medical gloves.

Rising awareness regarding latex allergies have led to increased innovation and technology breakthroughs in synthetic variants. The number of health care facilities going entirely latex-free continues to grow, as glove manufacturers work to create a synthetic product that matches the low cost and tactile sensitivity that have made natural rubber latex the longtime preference of surgeons and nurses.

Manufacturers witnessed a spike in sales of powder-free surgical gloves in 2014 according to GIA. Ansell North America, said powder-free surgical gloves were the fastest-growing medical product category in 2013 for Ansell.

In US, non-latex gloves sales grew at a rate of greater than 20 percent in the last fiscal year, driven by sales of the company’s Poly-Isoprene surgical gloves. The category includes the free of latex and chemical accelerators, and other type is 30 percent thinner than standard surgical gloves.

Health care workers’ preference for synthetic gloves continues to grow in the years ahead. Awareness involved increasing of latex (type I) and chemical (type IV) allergies, as well as the significant potential cost implications related to these reactions, which can range from a simple rash to a life-threatening anaphylactic event. Due to this awareness, Neoprene and Poly-Isoprene gloves have been embraced as an alternative to latex gloves and subsequently, latex free facilities are becoming more prevalent.

Glove Demand in Latin America

For Latin America, Brazil and Mexico are the two largest markets for medical gloves. In 2013, demand for the gloves in Brazil and Mexico are estimated at 2.5 billion pairs (US$249 million) and 1.3 billion pairs (US$102.8 million) respectively. For latex surgical glove, Brazil and Mexico recorded demand at 283.6 million pairs and 253.2 million pairs respectively.

The market growth in Latin America as a whole is driven mainly by healthcare reforms. Other factors affecting the growth in the region are population growth, ageing population and recurring H1N1 influenza virus outbreaks which increased physicians’ visits. New healthcare laws and regulations also have positive impacts to the increase of glove usage in this region. Consumption of latex surgical gloves and examination gloves accounted to 92% of the total glove demand.

3.0 TRADE STATISTICS

3.1 MULTILATERAL TRADE

a) Rubber and Rubber Products

i) Top Ten Suppliers of Rubber and Rubber Products to United States United States Import Statistics Commodity: Rubber & Rubber Products Year To Date: January - December

Partner US$ Million % Share % Change Rank Country 2014/2013 2012 2013 2014 2012 2013 2014 World 55,980.6 56,251.5 57,947.6 100.00 100.00 100.00 3.02 1 China 23,099.4 23,966.2 24,630.1 41.26 42.61 42.50 2.77 2 Vietnam 2,630.8 3,137.23,824.1 4.70 5.58 6.60 21.90 3 Mexico 3,598.7 3,597.43,753.6 6.43 6.40 6.48 4.34 4 Canada 3,562.2 3,343.43,255.4 6.36 5.94 5.62 - 2.63 5 Indonesia 3,646.9 3,476.0 3,128.9 6.51 6.18 5.40 - 9.99 6 Japan 2,969.3 2,722.9 2,651.4 5.30 4.84 4.58 - 2.62 7 Thailand 2,587.4 2,271.72,184.1 4.62 4.04 3.77 - 3.86 8 South Korea 2,206.4 1,863.4 1,860.7 3.94 3.31 3.21 - 0.14 9 Malaysia 1,441.9 1,435.7 1,430.1 2.58 2.55 2.47 - 0.39 10 Germany 1,260.5 1,253.01,339.4 2.25 2.23 2.31 6.90 Source: World Trade Atlas ii) Leading Rubber & Rubber Products Imported by United States United States Import Statistics Commodity: Rubber & Rubber Products Year To Date: January - December

US$ Million % Share % Change Commodity Description 2014/2013 2012 2013 2014 2012 2013 2014 Rubber & Rubber Products 55,980.6 56,251.5 57,947.6 100 100 100 3.02 New Tires 401110 7,423.5 7,840.9 7,677.1 13.26 13.94 13.25 -2.09 For Cars Footwear, Outer Sole 640399 6,363.3 6,653.8 6,490.5 11.37 11.83 11.2 -2.45 Rubber Footwear, Outer Sole 640299 4,929.5 4,871.7 4,751.8 8.81 8.66 8.2 -2.46 & Upper Rubber New Tires For Buses 401120 4,139.4 3,988.7 4,332.4 7.39 7.09 7.48 8.62 Or Trucks Footwear, Out Sole 640391 Rubber & Upper 3,518.1 3,706.8 4,284.8 6.28 6.59 7.39 15.59 Leather Source: World Trade Atlas

b) Rubber

iii) Top Ten Suppliers of Rubber to United States

United States Import Statistics Commodity: Rubber (Upstream) 4001-4006 Year To Date: January - December Partner US$ Million % Share % Change Rank Country 2012 2013 2014 2012 2013 2014 2014/2013 World 6,083.2 4,854.8 4,416.1 100.00 100.00 100.00 - 9.04 1 Indonesia 2,073.4 1,661.7 1,263.3 34.08 34.23 28.61 - 23.97 2 Canada 615.7 566.4 573.1 10.12 11.67 12.98 1.19 3 Thailand 714.5 428.1 344.1 11.74 8.82 7.79 - 19.62 4 Japan 302.9 272.1 275.5 4.98 5.61 6.24 1.25 5 South Korea 277.4 226.0 274.1 4.56 4.65 6.21 21.29 6 Germany 244.7 208.1 234.6 4.02 4.29 5.31 12.75 7 Mexico 294.8 186.7 221.8 4.85 3.85 5.02 18.77 8 France 213.6 196.7 200.4 3.51 4.05 4.54 1.92 9 Russia 146.9 186.8 163.2 2.41 3.85 3.70 - 12.62 10 Malaysia 144.8 114.0 100.1 2.38 2.35 2.27 - 12.26 Source: World Trade Atlas

iv) Leading Rubber Commodity Imported by United States

United States Import Statistics Commodity: Rubber (Upstream) 4001-4006 Year To Date: January - December US$ Million % Share % Change Commodity Description 2012 2013 2014 2012 2013 2014 2014/2013 Rubber (Upstream), 4001-4006 6,083.2 4,854.8 4,416.1 100 100 100 -9.04 4001 Natural Rubber 3,382.3 2,558.8 1,954.1 55.6 52.71 44.25 -23.63 4002 Synthetic Rubber 1,979.4 1,606.4 1,736.2 32.54 33.09 39.32 8.08 Compounded 592.0 571.4 602.7 9.73 11.77 13.65 5.48 4005 Rubber 4003 Reclaimed Rubber 61.2 51.2 48.8 1.01 1.05 1.11 -4.67 Unvulcanized 33.3 35.3 42.3 0.55 0.73 0.96 19.78 4006 Rubber 4004 Waste Of Rubber 35.1 31.6 32.0 0.58 0.65 0.72 1.15 Source: World Trade Atlas

6 c) Rubber Products a. Leading Suppliers of Rubber Products to United States

United States Import Statistics Commodity: Rubber Products CH40&NonCH40 Year To Date: January - December Partner US$ Million % Share % Change Rank Country 2012 2013 2014 2012 2013 2014 2014/2013 World 49,897.3 51,396.7 53,531.5 100.00 100.00 100.00 4.15 1 China 23,008.7 23,900.9 24,549.4 46.11 46.50 45.86 2.71 2 Vietnam 2,566.1 3,077.8 3,769.7 5.14 5.99 7.04 22.48 3 Mexico 3,304.0 3,410.6 3,531.8 6.62 6.64 6.60 3.55 4 Canada 2,946.5 2,777.0 2,682.3 5.91 5.40 5.01 - 3.41 5 Japan 2,666.3 2,450.8 2,375.9 5.34 4.77 4.44 - 3.05 6 Indonesia 1,573.5 1,814.3 1,865.5 3.15 3.53 3.48 2.82 7 Thailand 1,872.9 1,843.6 1,840.0 3.75 3.59 3.44 - 0.20 8 South Korea 1,929.0 1,637.4 1,586.7 3.87 3.19 2.96 - 3.10 9 Malaysia 1,297.1 1,321.6 1,330.0 2.60 2.57 2.48 0.64 10 Germany 1,015.8 1,044.9 1,104.8 2.04 2.03 2.06 5.73 Source: World Trade Atlas

MAJOR RUBBER PRODUCTS IMPORTED

(vi) Rubber Gloves (Surgical & Non-Surgical Gloves)

United States Import Statistics Commodity: Rubber Gloves Partner US$ Million % Share % Change Rank Country 2012 2013 2014 2012 2013 2014 2014/2013 World 2,116.2 2,069.72,039.6 100.00 100.00 100.00 - 1.45 1 Malaysia 1,125.2 1,137.9 1,100.4 53.17 54.98 53.95 - 3.30 2 Thailand 620.6 564.3 557.4 29.33 27.27 27.33 - 1.22 3 China 182.4 186.2 200.1 8.62 9.00 9.81 7.48 4 Indonesia 100.9 96.4 98.8 4.77 4.66 4.84 2.51 5 Sri Lanka 44.7 44.5 42.3 2.11 2.15 2.07 - 4.97 6 Vietnam 13.2 10.7 9.2 0.62 0.51 0.45 - 13.57 7 Mexico 10.2 8.8 9.2 0.48 0.42 0.45 4.83 8 Guatemala 5.7 6.3 8.0 0.27 0.31 0.39 25.95 9 Taiwan 3.2 3.5 3.5 0.15 0.17 0.17 0.06 10 India 1.8 1.5 2.7 0.09 0.07 0.13 78.92 Source: World Trade Atlas

(vii) Surgical Gloves

United States Import Statistics Commodity: 401511, Surgical And Medical Gloves Partner US$ Million % Share % Change Rank Country 2012 2013 2014 2012 2013 2014 2014/2013 World 322.2 316.8 352.9 100.00 100.00 100.00 11.38 1 Malaysia 143.2 161.5 170.8 44.44 50.96 48.39 5.76 2 Thailand 153.0 127.5 157.3 47.47 40.24 44.58 23.38 3 Sri Lanka 19.0 20.7 17.2 5.88 6.52 4.89 - 16.51 4 Indonesia 2.9 2.4 3.0 0.90 0.76 0.85 24.13 5 China 1.9 1.8 1.5 0.59 0.57 0.43 - 16.13 6 Italy 1.0 1.0 1.2 0.32 0.33 0.34 16.41 7 India 1.2 0.9 1.1 0.36 0.29 0.32 22.27 8 Austria 0.0 0.8 0.5 0.00 0.25 0.13 - 41.81 Dominican 9 - 0.1 0.2 0.00 0.04 0.06 88.45 Rep. 10 Netherlands - - 0.0 0.00 0.00 0.01 0.00 Source: World Trade Atlas

(viii) Non-Surgical Gloves United States Import Statistics Commodity: 401519, Gloves, Except Surgical And Medical Gloves, Of Vulcanized Rubber Partner US$ Million % Share % Change Rank Country 2012 2013 2014 2012 2013 2014 2014/2013 World 1,793.9 1,752.91,686.8 100.00 100.00 100.00 - 3.77 1 Malaysia 982.0 976.5 929.7 54.74 55.71 55.12 - 4.79 2 Thailand 467.7 436.8400.1 26.07 24.92 23.72 - 8.40 3 China 180.5 184.4198.6 10.06 10.52 11.77 7.71 4 Indonesia 98.0 94.095.8 5.46 5.36 5.68 1.96 5 Sri Lanka 25.7 23.8 25.0 1.44 1.36 1.48 5.04 6 Vietnam 13.2 10.79.2 0.73 0.61 0.55 - 13.57 7 Mexico 10.2 8.79.2 0.57 0.50 0.54 5.00 8 Guatemala 5.7 6.3 8.0 0.32 0.36 0.47 25.95 9 Taiwan 3.2 3.53.5 0.18 0.20 0.21 0.06 10 South Korea 1.9 2.0 2.1 0.11 0.11 0.13 5.07 Source: World Trade Atlas

(ix) Condoms

United States Import Statistics Commodity: 401410, Condoms Partner US$ Million % Share % Change Rank Country 2012 2013 2014 2012 2013 2014 2014/2013 World 34.3 30.5 31.2 100.00 100.00 100.00 2.23 1 Thailand 11.5 13.2 13.6 33.43 43.37 43.77 3.19 2 Malaysia 6.0 5.4 8.2 17.46 17.62 26.27 52.47 3 India 6.2 5.1 5.5 18.10 16.63 17.78 9.28 4 Japan 5.5 4.6 2.9 16.11 15.04 9.19 - 37.54 5 China 3.6 1.2 0.5 10.38 3.94 1.70 - 55.88 6 South Korea 0.7 0.8 0.3 1.90 2.47 1.04 - 57.13 7 Canada 0.0 - 0.1 0.00 0.00 0.17 0.00 8 Germany 0.1 0.3 0.0 0.26 0.88 0.08 - 91.14 9 Netherlands 0.0 - 0.0 0.02 0.00 0.00 0.00 10 Philippines 0.0 - - 0.00 0.00 0.00 0.00 Source: World Trade Atlas

3.2 BILATERAL TRADE

(i) Malaysia’s Trade with United States of America – Rubber and Rubber Products

Export Import Total Trade Trade Balance Year Value in RM Million 2010 4,019.90 438.76 4,458.65 3,581.14 2011 4,201.29 388.46 4,589.75 3,812.82 2012 4,430.18 363.47 4,793.66 4,066.71 2013 4,355.80 294.18 4,649.99 4,061.62 2014 4,478.59 312.36 4,790.96 4,166.23 Source: Department of Statistic

a) Rubber Products

(ii) Malaysia’s Export of Rubber Products to USA (By Sector)

Rubber Products (RM Million) Year Inner Latex Footwear GRG IRG Tires Total Tubes Goods 2010 10.18 167.06 46.46 0.38 3,357.20 3.40 3,584.67 2011 6.98 158.48 68.63 0.45 3,451.57 37.19 3,723.31 2012 6.83 152.79 83.05 0.55 3,766.99 29.94 4,040.15 2013 7.07 162.34 74.61 0.70 3,706.37 64.22 4,015.32 2014 4.64 189.82 91.94 0.59 3,734.86 176.07 4,197.90 Source: Department of Statistics, Malaysia

(iii) Malaysia’s Import of Rubber Products from USA (By Sector)

Rubber Products (RM Million) Year Inner Latex Footwear GRG IRG Tires Total Tubes Goods 2010 14.11 101.05 143.83 0.04 19.28 9.18 287.48 2011 23.55 94.97 43.11 0.08 12.58 7.37 181.67 2012 13.91 118.20 78.39 0.20 13.87 6.43 231.00 2013 7.08 131.52 61.45 0.19 25.77 7.33 233.34 2014 7.17 127.92 62.96 0.11 24.56 9.10 231.81 Source: Department of Statistics, Malaysia

(iv) Malaysia’s Export of Rubber Products in 2014 (By Destination)

Value % Rank Country (RM Million) Share 1 USA 4,197.90 27.67 2 GERMANY 1,046.98 6.9 3 JAPAN 988.14 6.51 4 UK 599.96 3.95 5 CHINA 592.40 3.9 6 AUSTRALIA 575.31 3.79 7 BRAZIL 545.87 3.6 8 SINGAPORE 484.74 3.2 9 ITALY 376.34 2.48 10 BELGIUM 323.90 2.13 ROW 5,439.36 35.85 Total: 15,170.89 100.00 Source: Department of Statistics, Malaysia

(v) Latex Products

Malaysia's Export of Latex Products To United States of America % (RM Million) CAGR % DESCRIPTION SHARE 2010-2014 2010 2011 2012 2013 2014 2014 Non-Surgical Glove 2,933.1 3,015.3 3,301.2 3,083.6 3,077.5 82.40 0.97 Surgical Glove 326.8 337.9 341.7 398.4 444.2 11.89 6.33 Other Articles Of Apparel 15.0 15.0 16.6 114.6 112.52 3.01 49.63 And Clothing Accessories Catheters 37.7 41.463.8 64.78 56.14 1.508.29 Condoms 17.0 15.320.5 23.01 28.41 0.7610.82 Other Hygienic And Pharmaceutical Rubber 6.6 7.9 9.7 8.74 7.91 0.21 3.69 Articles Latex Thread 18.7 15.5 9.3 6.88 5.35 0.14 -22.14 Teats And Soothers 0.8 1.3 2.3 1.8 0.91 0.02 2.61 Foam Products 0.7 1.0 0.6 3.48 0.91 0.02 5.39 Rubber Thread & Cord 0.5 0.4 - 0.78 0.61 0.02 4.06 Finger Stalls 0.3 0.5 0.4 0.36 0.39 0.01 5.39 Total 3,357.2 3,451.63,766.1 3,706.4 3,734.8 100 2.15 Source: Department of Statistics, Malaysia

4.0 IMPORT REGULATION

MEDICAL DEVICE REGULATION IN THE U.S.

Medical devices must meet all FDA regulations prior to being imported into the United States. One of the first things foreign medical device manufacturers must be aware of is that FDA does not recognize regulatory approvals from foreign countries.

The term medical device under the Food Drug and Cosmetic Act (FDCA) refers to instruments, machines, implants, in vitro reagents, and similar or related articles, including component parts or accessories which are 1) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or 2) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body and is not dependent upon being metabolized for the achievement of any of its primary intended purposes.

Medical devices fall into one of three classes. Class 1 medical devices are those with the lowest level of risk associated with them. If a Class 1 medical device failed or became defective, there would be no significant injury or harm to the patient or user. Class 2 medical devices carry greater risk. If a Class 2 medical device failed or became defective, there would be a risk that the patient or the user could be injured or harmed. Class 3 medical devices carry the greatest risk. If a Class 3 medical device failed or became defective, there would be a risk of serious injury or death to the patient or the user. FDA classifies medical devices and, in many cases, has issued regulations stating the classifications and requirements for medical devices. However, as medical device technology advances, in many instances a new medical device does not fall easily into an existing medical device classification or category. Therefore, there is a regulatory process in which medical device manufacturers and distributors can ask FDA to classify a new medical device.

Like all other FDA regulated articles, medical devices must be properly labeled, must be manufactured according to specific standards, must obtain all pre-clearances before being imported into the U.S., and must be manufactured in appropriate (registered) facilities. Foreign medical device manufacturers must register with FDA under the FDA Device Establishment Registration regulations and must appoint a U.S. Agent for FDA purposes. FDAImports.com, LLC acts as U.S. Agent for foreign medical device clients, ensuring that all required data is submitted to FDA prior to shipping medical devices to the U.S. and that all substantive clearance, labeling, and listing requirements are also met.

Importers of medical devices must also register with FDA as device establishments acting as medical device initial distributors. FDA expects U.S. importers to understand and ensure compliance with FDA laws and regulations related to medical devices, medical device manufacturing, and medical device clearances (510(k)s) and FDA approvals (PMAs) when required. FDAImports.com, LLC represents medical device importers, showing them The Way Through the FDA and Customs importation process for importing medical devices.

Source: http://fdaimports.com/industries/medical_devices/

5.0 TARIFF & NON TARIFF BARRIERS

5.1 Tariff Barriers

5.1.1 Import Tax

HS Code Description Import Duties 40151101 Surgical gloves Free 40151905 Non-surgical gloves Free 40141000 Sheath contraceptives (Condoms) Free 90183900 Catheters Free 40149010 Finger stalls Free 40149050 Other Hygienic And Pharmaceutical Rubber Articles 4.2% 40159000 Articles of apparel and clothing accessories 4.0% 56041000 Rubber thread and cord, textile covered 6.3% 40070000 Vulcanized rubber thread and cord Free

5.1.2 VAT (Value Added Tax)

a. VAT for Medical Devices: 0% (Examination glove, surgical glove, condom, etc.) b. VAT for Non-Medical Devices: Up to 3% (Cleanroom glove, household glove. etc.)

Non-tariff Barriers

5.2.1 Premarket Notification 510(k)

Each person who wants to market in the U.S., a Class I, II, and III device intended for human use, for which a Premarket Approval (PMA) is not required, must submit a 510(k) to FDA unless the device is exempt from 510(k) requirements of the Federal Food, Drug, and Cosmetic Act (the Act) and does not exceed the limitations of exemptions in .9 of the device classification regulation chapters (e.g., 21 CFR 862.9, 21 CFR 864.9). There is no 510(k) form, however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission. Before marketing a device, each submitter must receive an order, in the form of a letter, from FDA which finds the device to be substantially equivalent (SE) and states that the device can be marketed in the U.S. This order "clears" the device for commercial distribution.

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed deviceThe following four categories of parties must submit a 510(k) to the FDA:

i. Domestic manufacturers introducing a device to the U.S. market ii. Specification developers introducing a device to the U.S. market iii. Repackers or relabelers who make labeling changes or whose operations significantly affect the device iv. Foreign manufacturers/exporters or U.S. representatives of foreign manufacturers/exporters introducing a device to the U.S. market.

5.2.2 Determining Admissibility/Customs Examination of Goods

In simple cases involving small shipments, examination may be made on the docks, at container stations, cargo terminals, or the importer’s premises. The merchandise may be retained by Customs for appraisal or classification purposes and the remainder of the shipment released. These sample packages will also be released to the importer after examination. Examination of goods is necessary to determine: i. The value of the goods for Customs purposes and their dutiable status. ii. Whether the goods are properly marked with the country of their origin. Generally, imported merchandise must be legibly marked in a conspicuous place and with the English name of the country of origin. iii. Whether the goods have been correctly invoiced. iv. Whether the shipment contains prohibited articles. v. Whether the requirements of other federal agencies have been met. vi. Whether the amount of goods listed on the invoice is correct, and no shortage or overage exists.

If necessary, goods may be analyzed by a Customs laboratory to determine proper classification and appraisal, to determine that the goods meet safety requirements, or to ensure that they are not counterfeit or otherwise in violation of U.S. laws.

6.0 FREE TRADE AGREEENT (FTA)

The Malaysia-US Free Trade Agreement is a proposed treaty between Malaysia and the United States of America. The treaty aims to liberalize each other markets to parties of the agreement and directly encourage trade between the two countries.

Several rounds were held to discuss matters that proved to be sticky for both sides. The US was working to achieve an agreement before the Trade Promotion Authority lapsed in July 2007; the TPA is an authority granted by the US Congress to the US President to fast track free trade negotiations between the US and foreign states. Despite the deadlines, both the US and the Malaysian sides were unable to move forward and hence, negotiation is still ongoing.

The issues affecting the negotiation are high tariffs imposed on imported US goods compared to imported Malaysian goods, restriction of import of motor vehicles into Malaysia, government procurement policy, export subsidies, intellectual property rights, pharmaceutical, barriers in various services and investment requirements.

7.0 TRANS-PACIFIC PARTNERSHIP

The Trans-Pacific Partnership (TPP) is a proposed trade agreement between several Pacific Rim countries concerning a variety of matters of economic policy. Among other things, the TPP seeks to lower trade barriers such as tariffs, establish a common framework for intellectual property, enforce standards for labor law and environmental law, and establish an investor-state dispute settlement mechanism. The goal of the agreement is to "enhance trade and investment among the TPP partner countries, to promote innovation, economic growth and development, and to support the creation and retention of jobs.

The Trans-Pacific Partnership will grow trade with one of the world’s fastest growing regions, and share American values and commitment to improve labor practices and elevate environmental standards around

the world. The United States is negotiating the TPP with 11 other like-minded countries (Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam) that share a commitment to concluding a high-standard, ambitious agreement and to expanding the initial group to include additional countries throughout the Asia-Pacific region. We are in the endgame of negotiations, making TPP the most promising platform for Asia-Pacific regional trade integration.

The TPP is the cornerstone of the Obama Administration’s economic policy in the Asia Pacific. The large and growing markets of the Asia-Pacific already are key destinations for U.S. manufactured goods, agricultural products, and services suppliers, and the TPP will further deepen this trade and investment. As a group, the TPP countries are the largest goods and services export market of the United States. U.S. goods exports to TPP countries totaled $698 billion in 2013, representing 44 percent of total U.S. goods exports. U.S. exports of agricultural products to TPP countries totaled $58.8 billion in 2013, 85 percent of total U.S. agricultural exports. U.S. private services exports totaled $172 billion in 2012 (latest data available), 27 percent of total U.S. private services exports to the world. America’s small- and medium- sized enterprises alone exported $247 billion to the Asia-Pacific in 2011.

8.0 MAJOR MEDICAL DEVICES SUPPLIERS IN USA

Company Name Description Edan USA Edan USA was established in 2009 to offer local service and support for U.S. sales. The company stock over one million dollars’ worth of inventory in their warehouse and sell equipment through distribution network that consists of over 100 resellers across the United States. Trans Med USA Trans Med USA Inc. was established in 1986, distributing for over 100 different Inc. reputable manufacturers of varying types of Durable Medical Equipment, hospital disposables, and hospital furnishings. US MED US MED and its family of companies is America’s choice for home delivery of quality medical supplies and medications. Over 200,000 satisfied patients have received supplies from them. With licensed and accredited by the Accreditation Commission for Health Care, United States Medical Supply is reputable to deliver quality care with 100% Satisfaction Guarantee. AmerCare AmerCare is one of North America's leading suppliers of high quality latex and synthetic gloves. Sold through distributors, AmerCare's glove products are used in the medical, janitorial, food service, and a variety of other fields. Henry Schein Henry Schein surgical gloves are ideal for practitioners of medicine who require a Medical sterile, sized glove offering exceptional tactile sensitivity and natural feel. AMMEX AMMEX Corporation is the premier importer and distributor of high quality Corporation disposable gloves and barrier protection products. AMMEX supplies a wide selection of disposable gloves and personal protection equipment to thousands of distributors in a variety of industries.

Omar, Inc Omar Medical Supplies, manufactures and supplies glove. Dipped Products DPL is a fully integrated rubber glove manufacturer that produces a continuing PLC stream of high-value new-product innovations in protective hand wear. Emerald Major importer and wholesaler of vinyl, nitrile & latex gloves, single-use disposables Professional and other infection control items. Protection Products Medline Medline is America's largest provider of medical supplies and solutions, family-led for four generations. Adenna Inc. The company market and distribute a variety of hand protection and healthcare product; including medical examination gloves, general-purpose disposable gloves, face masks, self-sealing sterilization pouches and others to the medical, dental, laboratory, veterinary, food services, auto and other industries.

9.0 USEFUL CONTACTS

i. Embassy of Malaysia, Washington DC

Address : Embassy of Malaysia 3516 International Court New Washington Washington DC 20008 Tel : +1 202 572 9700 Fax : +1 202 572 9882 Email : [email protected] Contact Person : H.E. Datuk Dr. Awang Adek Hussin (The Ambassador)

ii. Consulate General, New York

Address : 313 East, 43rd Street, 10017, New York Tel : +1 212 490 2722 Fax : +1 212 490 2049 Email : [email protected] Contact Person : H.E. Abd Razak Abdul Wahab (Consul General)

iii. Malaysia Trade Development (MATRADE New York)

Address : 3rd Floor, 313 East, 43rd Street New York, NY 10017 USA Tel : +1 212 682 0232 Fax : +1 212 983 1987 Email : [email protected] Contact Person : Muhd Shahrulmiza Zakaria (Trade Commissioner)

iv. Malaysia Trade Development (MATRADE Miami)

Address : Malaysia Trade Center, 703 Waterford Way, Suite 150, Miami, Florida 33126 USA. Tel : +1 305 267 8779 Fax : +1 305 267 8784 Email : [email protected] Contact Person : Muhd Shahrulmiza Zakaria (Trade Commissioner)

v. Malaysia Trade Development (MATRADE Los Angeles)

Address : Consulate General of Malaysia Commercial Section (MATRADE) 550 South Hope Street, Suite 400 Los Angeles CA 90071 USA Tel : +1 213 892 9034 Fax : +1 213 955 9142 Email : [email protected] Contact Person : Rusiah Mohamed (Trade Commissioner)

vi. Malaysian Rubber Export Promotion Council (MREPC) USA

Address : Malaysian Rubber Export Promotion Council (MREPC) 3516, International Court, N.W. Washington D.C. 20008 Tel : +1 202 572 9771/9721 Fax : +1 202 572 9787 Mobile : +1 202 316 1211 Email : [email protected] Contact Person : Dr Esah Yip (Director, US Office)

vii. American Hospital Association

Address : 800 10th Street, N.W. Two CityCenter, Suite 400 Washington, DC 20001-4956 Tel : 1 800 424 4301 Website : http://www.aha.org/

17 viii. U.S. Food and Drug Administration

Address : 10903 New Hampshire Avenue Silver Spring, MD 20993 Tel : 1 888 463 6332 Website : http://www.fda.gov/

ix. American Health Care Association

Address : 1201 L Street, N.W., Washington, DC 20005 Tel : +1 202 842 4444 Fax : +1 202 842 3860 Email : [email protected] Website : http://www.ahcancal.org

10.0 TRADE FAIRS

No. Trade Fairs Description Cycle 1. ADVAMED Event dedicated to medical devices, San Diego, CA diagnostic products and health information Once a year

systems.

2. MEDTECH POLYMERS Focused Forum & expo for the Plastics and HOUSTON Medical community. Once a year Houston, TX 3. GNYDM - GREATER NEW- New York International Dental Meeting. YORK DENTAL MEETING GNYDM features over 1500 Technical Once a year New York, NY Exhibits which demonstrated the newest technology for the dental profession 4. BIOMEDEVICE SAN JOSE A unique forum bringing together world-class San Jose, CA medical device designers, engineers, researchers and manufacturers to share how Once a year to foster and support innovation in medical device design. 5. MD&M EAST SHOW Medical Design and Manufacturing Show, New York, NY Exhibition & Conference. Medical Design & Once a year Manufacturing East connects medical device development professionals to the inspiration,

partnerships, education, & technologies needed to drive medical device innovation 6. FIME International Medical Equipment Expo. FIME Miami, FL is the number one exhibition for medical dealers, distributors, hospitals group purchasing organization & medical Once a year professionals seeking the latest medical products