Example Sample1 process flow.

Seep Description Seep Description Receive raw material 1. Incoming material QC from supplier and test （Visual Inspection） Mfg. Sterilization (EOG） 9. Sterilization Mfg. (Quality conformance inspection) DEF STU (BI testing) Assembly 2. Assembly 1 (Determination of （Injection molding process） residual ethylene oxide)

Test 3. Test１ （Visual Inspection) Test 10. Test4 (Electric resistance measurement ) (Visual Inspection) Mfg. Mfg. ISO Class 7 GHI ABC Assembly 4. Assembly 2 （Welding process） Storage （Coating）

Cleaning 5. Cleaning Test 11. Test 5 6. Test 2 （Visual Inspection） Test （Visual Inspection) Packaging / Labeling (Leakage current measure) Mfg. 12. Outer containers JKL Cleaning / Packaging / 7. Cleaning/Packaging/Labeling Labeling 13.Final Inspection （ ） Final Inspection Cleaning （Visual Inspection） （Sterilized packaging process）

Test 8. Test 3 Decision on whether the （Visual Inspection） products an be shipped （Bio burden testing） Registration 0 Example Sample2 Mutual relations of QMS

Marketing Authorization Holder（JKL, Ltd.） Agreement 実地調査QMS(ABC, Co.）

MNO, Co.(Registration) Design facility GHI Distribution Center （Inspection・Storage） ABC Mfg. site STU, Mfg. site. (Registration) Assembling plant Main assembling plant

Agreement JKL Distribution Center QMS(DEF, Co.) (Registration) ：Same QMS （Distribution Center） DEF, Mfg. site(Registration) ： （Sterilizer） Information exchange

1 Example Form2 Outline of MAH/RMS (1/2)

Outline of manufacturing site As of DD/MM/YY Name of mfg . site Address of mfg. site Registration number Date of initial registration Registration period Numbers of employees (including part time employees) Total: Mfg. department : QA/QC department : Number of mfg. products (Number of products exported to Japan should be described in parenthesis.) Class I Class II Class III Class IV Number of products

Product utilizing medicine/cellular and tissue-based product Specified biological product

Product utilizing nano materials Micro

Product absorbed into human body Special designated medical device 2 Example Form2 Outline of RMS (2/2)

If export , please describe your export destination and trade name of the products except Japan.

Export destination Trade name of the product

Changes history of mfg. site  Changes of product / mfg. process (if important) (please select items, and specify  Changes of QMS organization details.)  Changes of top or management representative  Others ( )  No Change Details

Not applied article 4 and article 83 of QMS ordinance (MHLW Ministerial Ordinance No.169 in 2004)

History of QMS inspections by regulatory authorities and registered certification body over the past 5 years.

Name regulatory Inspection date The products subject to Inspection results Type of Inspection authorities/registered the inspection (On-site or Desk-top) certification body

Name, address, and applicable mfg. process of critical suppliers

Name Address Applicable mfg. process

3 Example Form3 Products list for application

No. Product Generic Trade Approval classification Date of Expiry * Mfg. site family name name (certification) approval date registration No. (Certification)

1

2

3

4

5

6

* If sterilizer or distribution center are different, write these mfg. site’s name.

4 Example Sample3 Layout of RMS

Location map of RMS

Aerial photograph Site boundary of or location map of RMS RMS.

S Building Distinguish a Q Building building affecting a subject of product.

T Building

R Building

Medical devices mfg. building

5 Example Sample4 Floor plan of RMS(1/2)

ISO Class 7 a passage way differential pressure

Manufacturing Manufacturing (>10Pa)

Sterilizer

Receiving People flow

Packaging Material flow

Shipping Sterilization

Sterilizer 1 Sterilizer 2

6 Example Sample4 Floor plan of RMS(2/2)

Representative list of mfg. equipment

No. Manufacturing Equipment Model １ Injection Molding Equipment SK-123 ２ Welding Equipment Ly-222 ３ Autoclave ST999 ・・・・・・

Representative list of inspection equipment

No. Inspection Equipment Model １ Gage Blocks 123F ２ Microscope F111 ３ Electronic scale SEW124 ・・・・・・

7 Example Sample5 organization chart

ABC company Organization Chart

PMDA TARO President and CEO Top Management

KIKOU JIRO Human Quality & Regulatory Affairs Finance Global Resource Reconstruction operation Management Representative

Regulatory Mfg QA Affairs department department department

Mfg. site A QC department

Mfg. site B Purchasing department 8 Sample6 Example List of documents identified with QMS

Control of Documents identified with the Retention QMS Article documents QMS period Name Number Section 2 QMS Article 5 General equirements for QMS Article 6 6.1.1 Quality policy Documentation of QMS 6.1.1 Quality objectives 6.1.2 The quality manual Any other documentation 6.1.5 specified by the laws, others and ordinances related to the PMD Act. 6.2 Seihin hyojun syo Article 7 Quality Manual Article 8 Procedure about control of 8.2 Control of Documents documents Article 9 Procedure about control of 9.2 Control of Records records

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9 Example Sample7 Seihin Hyojyun Syo

Location Requirements Reference documents(name, number, etc) (sites)

1.Product family, Generic name (common name), Proprietary name Copy of marketing approval

2.The date of number of approval Copy of marketing approval Product Specification 3.Specifications (P2/D2 DMF1 device requirement spec 73345) 4.Operating methods and procedure Product Manual 7233

Mechanical Specification 7810 (Spec-controlled environment area) 5.Product design, drawings and specifications or composition and Test specification T78910 content (Electrical test specification, IPG) Product Specification P78910 (DMF1 RV2 product configuration)

6.Mfg methods and procedure Mfg procedure(MT123, SOP04, SOP05) *************** *************** Product Specification 1234 8.Labeling and packaging (P2/D2 DMF1 device requirement spec) *************** ***************

10 Sample8 Example Implementation of validation status

Mfg Validation date Mfg. Reasons Mfg equipment process IQ OQ PQ site Injection N/A N/A 1/3/2014 ABC Re-Validation Injection molding molding machine A-01

Soldering 1/1/2014 1/2/2014 1/3/2014 ABC Repairing Soldering Soldering iron D-01, iron D-01, D-02 D-02

Welding 1/1/2014 1/2/2014 1/3/2014 ABC Change equipment Ultrasonic welding machine M-01

Sterilization 1/1/2014 1/2/2014 1/3/2014 DEF Purchase new Sterilizer P-04 sterilizer(EOG)

Packing N/A 1/2/2014 1/3/2014 ABC Change setting value Heat Sealer P-01 （Temp:105℃→110℃）

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