1、 1 Tentative translation ver. 3.1 (as of 5 September 2005) 1MHLW Ministerial Ordinance No. 169, 2004 In accordance with the provisions of Item (4) of Paragraph 2 of Article 14 and Item (4) of Paragraph 2 of Article 14 applied mutatis mutandis under Paragraph 5 of Article 19-2 of Pharmaceutical Affai
2、rs Law (Law No. 145, 1960), MHLW Ministerial Ordinance on Standards for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents is established as follows. 17 December 2004 Hidehisa OTSUJI Minister of Health, Labour and Welfare Ministerial Ordinance on Standards
3、 for Manufacturing Control and Quality Control for Medical Devices and In-vitro Diagnostic Reagents CONTENTS Chapter 1 General Provisions (Articles 1 to 3) Chapter 2 Manufacturing Control and Quality Control in Manufacturing Sites of Medical Device Manufacturers, etc. Section 1 General Rules (Articl
4、e 4) Section 2 Quality Management System (Articles 5 to 9) Section 3 Management Responsibility (Articles 10 to 20) Section 4 Resource Management (Articles 21 to 25) Section 5 Product Realisation (Articles 26 to 53) Section 6 Measurement, Analysis and Improvement (Articles 54 to 64) Chapter 3 Manufac
5、turing Control and Quality Control in Manufacturing Sites of Labelling, etc.-Category Medical Device Manufacturers, etc. (Articles 65 to 72) Chapter 4 Manufacturing Control and Quality Control in Manufacturing Sites of Biological-origin Medical Device, etc. Manufacturers, etc. (Articles 73 to 79) Ch
6、apter 5 Manufacturing Control and Quality Control in Manufacturing Sites of In-Vitro Diagnostic Reagents Manufacturers, etc. (Article 80) Supplementary Provisions 1Note/ This is a tentative translation of afore-mentioned Ordinance in English which is not an authentic and not formally autholised by M
7、inistry of Health, Labour and Welfare of Japan. 2Chapter 1 General Provisions Section 1 General Rules (Purpose) Article 1 This Ministerial Ordinance shall provide the standards in accordance with the provision of Item (4) of Paragraph 2 of Article 14 (including the case where it is applied mutatis m
8、utandis under Paragraph 5 of Article 19-2, and hereinafter referred to as such) of Pharmaceutical Affairs Law (Law No. 145, 1960) (hereinafter referred to as “Law”) which provides that such standards shall be provided by MHLW Ministerial Ordinances. (Definitions) Article 2 “Product” throughout this
9、Ministerial Ordinance means the object (including those which have undergone the intermediate process and need to undergo subsequent process to be the (final) products (hereinafter referred to as “intermediate products”) that has undergone the manufacturing process in the manufacturing site. 2. “Con
10、stituent parts, etc.” throughout this Ministerial Ordinance mean the parts, assemblies (limited to those which are used in the products), raw materials, materials, containers, wrappers, labellings (including the package inserts, and hereinafter referred to as such), etc. used in the manufacturing pr
11、ocess that constitute parts of the products, as well as the software of the products. 3. “Process agent” throughout this Ministerial Ordinance means the object that is used for the intermediate products in the manufacturing process (excluding those that constitute parts of the products). 4. “Packagi
12、ng and labelling material” throughout this Ministerial Ordinance means the container, wrapper and labelling among the constituent parts, etc. 5. “Lot” throughout this Ministerial Ordinance means a grouping of the products, process agents or constituent parts, etc. (hereinafter collectively referred
13、to as “products, etc.”) that are manufactured so as to have a uniform quality in a series of the manufacturing process for a certain manufacturing period. 6. “Batch for testing” throughout this Ministerial Ordinance means a lot or another grouping equivalent thereto of the products with a uniform qu
14、ality. 7. “Controlled unit” throughout this Ministerial Ordinance means a grouping of the packaging and labelling materials that have been verified to be same. 8. “Sterile medical device” throughout this Ministerial Ordinance means a medical device that is sterilised in the manufacturing process. 9.
15、 “Validation” throughout this Ministerial Ordinance means to verify and document that the buildings and facilities of the manufacturing site, procedures, processes and other procedures of the manufacturing control and quality control (hereinafter referred to as “manufacturing procedure, etc.”) provi
16、de the anticipated results. 3 10. “Clean area” throughout this Ministerial Ordinance means the place, among those areas where the manufacturing operations are conducted (hereinafter referred to as “work areas”), where the weighing operations for the constituent parts, etc. or the formulating operati
17、ons are conducted or where the cleaned containers are exposed to the air in the work areas. 11. “Aseptic area” throughout this Ministerial Ordinance means the place, among the work areas, where the aseptic products or constituent parts, etc. or sterilised containers are exposed to the air in the wor
18、k areas, where the sealing operations for the containers are conducted, or where the aseptic operations including the sterility tests are conducted. 12. “Cell/tissue-based medical device” throughout this Ministerial Ordinance means the medical device composed of human or animal cells or tissue. 13.
19、“Donor” throughout this Ministerial Ordinance means the person who donates the cells or tissue that serves as the materials for the cell/tissue-based medical devices (excluding those concerned with the body of a brain-dead person specified in Paragraph 2 of Article 6 of Law on Organ Transplantation
20、(Law No. 104, 1997). 14. “Donor animal“ throughout this Ministerial Ordinance means the animal which provides the cells or tissue that serves as the materials for the cell/tissue-based medical devices. 15. “Input” throughout this Ministerial Ordinance means the information, etc. necessary for the ma
21、nufacturing control and quality control when conducting a certain process. 16. “Output” throughout this Ministerial Ordinance means the information, etc., that is obtained as a result of a certain process conducted. 17. “Top management” throughout this Ministerial Ordinance means the person or the g
22、roup of people, including the executive officer who conducts the duties concerned with the manufacturing site, who directs and controls the manufacturing site. 18. “Quality policy” throughout this Ministerial Ordinance means the overall intentions and direction of the manufacturing site related to t
23、he quality as formally provided and expressed by the top management in order to ensure the quality of the products. 19. “Quality management system” throughout this Ministerial Ordinance means the management system that the manufacturer and the foreign manufacturer specified in Paragraph 1 of Article
24、 13-3 of Law (hereinafter simply referred to as “foreign manufacturer”) (hereinafter collectively referred to as “manufacturer, etc.”) direct and control the manufacturing site with regard to quality. 20. “Review” throughout this Ministerial Ordinance means the activity undertaken to determine the s
25、uitability, adequacy and effectiveness of the subject matter to achieve the established objectives. 21. “Resource” throughout this Ministerial Ordinance means the personal knowledge and skills and technology, facilities and other resource that is utilised for the operations of the manufacturing site
26、. 422. “Infrastructure” throughout this Ministerial Ordinance means the system of the facilities, equipment and services that are necessary for the operations of the manufacturing site. 23. “Traceability” throughout this Ministerial Ordinance means the ability to trace the history, application or lo
27、cation of that which is under consideration. 24. “Advisory notice” throughout this Ministerial Ordinance means the document that is issued subsequent to the delivery of the products to provide supplement any information or to advise what actions should be taken in use, modification, return or destru
28、ction of the products. (Scope) Article 3 The marketing authorisation holder of the medical devices or in-vitro diagnostic reagents specified in Paragraph 1 of Article 14 of Law, the appointed marketing authorisation holder of medical devices or in-vitro diagnostic reagents specified in Paragraph 4 o
29、f Article 19-2 of Law or the marketing authorisation holder of the designated controlled medical devices specified, etc. in Paragraph 1 of Article 23-2 of Law (hereinafter collectively referred to as “marketing authorisation holder, etc.”) shall, in accordance with the provision of Chapter 2 or the
30、provision of Chapter 2 applied mutatis mutandis under Chapter 5, have the manufacturer, etc. conduct the manufacturing control and quality control of the products in the manufacturing site, with the proviso that the manufacturing control and quality control in the manufacturing site of the manufactu
31、rer in the category specified in Item (4) of Paragraph 5 of Article 26 of Pharmaceutical Affairs Law Enforcement Regulations (MHW Ministerial Ordinance No. 1, 1961) (hereinafter referred to as “Enforcement Regulations”) (hereinafter referred to as “labelling, etc.-category medical device manufacture
32、r”) or the foreign manufacturer in the category specified in Item (4) of Paragraph 4 of Article 36 of Enforcement Regulations (hereinafter referred to as “foreign labelling, etc.-category medical device manufacturer”) (hereinafter collectively referred to as “labelling, etc.-category medical device
33、manufacturer, etc.”), or the manufacturer in the category specified in Item (3) of Paragraph 2 of Article 26 of Enforcement Regulations (hereinafter referred to as “labelling, etc.-category in-vitro diagnostic reagents manufacturer”) or the foreign manufacturer in the category specified in Item (3)
34、of Paragraph 2 of Article 36 of Enforcement Regulations (hereinafter referred to as “foreign labelling, etc.-category in-vitro diagnostic reagents manufacturer”) (hereinafter collectively referred to as “labelling, etc.-category in-vitro diagnostic reagents manufacturer, etc.”) are conducted in acco
35、rdance with the provision of Chapter 3 or the provision of Chapter 3 applied mutatis mutandis under Chapter 5 may be applied, instead of the provision of Chapter 2 or the provision of Chapter 2 applied mutatis mutandis under Chapter 5. 2. The marketing authorisation holder, etc. of medical devices s
36、hall have the manufacturer of the products concerned with the medical devices which correspond to the biological-origin products specified in Paragraph 9 of Article 2 of Law (hereinafter referred to as “biological-origin medical devices”), the medical devices designated by Minister of Health, Labour
37、 and Welfare in accordance with the provision of Paragraph 2 of Article 43 of Law, or the cell/tissue-based medical devices (hereinafter collectively referred to as “biological-origin medical devices, etc.”) (hereinafter referred to as 5 “biological-origin medical devices, etc. manufacturer”), and t
38、he foreign manufacturer of the products concerned with the biological-origin medical devices, etc. (hereinafter collectively referred to as “biological-origin medical devices, etc. manufacturer, etc.”) conduct the manufacturing control and quality control of the products in the manufacturing site in
39、 accordance with the provision of Chapter 4 (limited to Articles 78 and 79 for the manufacturing site that conducts only the labelling, packaging or storing operations) in addition to the provision of Chapter 2. 3. The manufacturer, etc. of medical devices or in-vitro diagnostic reagents shall condu
40、ct the manufacturing control and quality control of the products in the manufacturing site specified in Article 96 of Enforcement Regulations in accordance with the provision of Chapter 2 or the provision of Chapter 2 applied mutatis mutandis under Chapter 5, with the proviso that the manufacturing
41、control and quality control in the manufacturing site of the labelling, etc.-category medical device manufacturer, etc. or the labelling, etc.-category in-vitro diagnostic reagents manufacturer, etc. are conducted in accordance with the provision of Chapter 3 or the provision of Chapter 3 applied mu
42、tatis mutandis under Chapter 5, instead of the provision of Chapter 2 or the provision of Chapter 2 applied mutatis mutandis under Chapter 5. In addition, the manufacturing control and quality control of the products in the manufacturing site of the biological-origin medical device, etc. manufacture
43、r, etc. shall be conducted in accordance with the provision of Chapter 4 (limited to Articles 78 and 79 for the manufacturing site that conducts only the labelling, packaging or storing operations) in addition to the provision of Chapter 2. 4. The manufacturer of the products concerned with the medi
44、cal devices or drugs (limited to in-vitro diagnostic reagents, and referred to as such in this Paragraph 4) for the export specified in Paragraph 1 of Article 80 of Law shall conduct the manufacturing control and quality control of the products in the manufacturing site in accordance with the provis
45、ion of Chapter 2 or the provision of Chapter 2 applied mutatis mutandis under Chapter 5, with the proviso that the labelling, etc.-category medical device manufacturer or the labelling, etc.-category in-vitro diagnostic reagents manufacturer conducts the manufacturing control and quality control of
46、the products concerned with the medical devices or in-vitro diagnostic reagents for the export in accordance with the provision of Chapter 3 or the provision of Chapter 3 applied mutatis mutandis under Chapter 5, instead of the provision of Chapter 2 or the provision of Chapter 2 applied mutatis mut
47、andis under Chapter 5. In addition, the manufacturing control and quality control of the products concerned with the medical devices for the export specified in same Article of Law in the manufacturing site of the biological-origin medical devices, etc. manufacturer shall be conducted in accordance
48、with the provision of Chapter 4 (limited to Articles 78 and 79 for the manufacturing site that conducts only the labelling, packaging or storing operations) in addition to the provision of Chapter 2. Chapter 2 Manufacturing Control and Quality Control in Manufacturing Sites of Medical Device Manufac
49、turers, etc. Section 1 General Rules (Application) Article 4 The provisions of Articles 30 to 36 shall not apply to the products concerned 6 with the medical devices other than both the specially designated medical devices specified in Paragraph 1 of Article 77-5 of Law and the medical devices designated by Minister of Health, Labour and Welfare as those of which design and development (hereinafter referred to as “design and development”) are necessary to be controlled to ensure that the manufacturing control and quality control are conducted appropriately. 2. The manufacturer, etc., in case
