日本厚生劳动省169法令.docx

Tentative translation ver. 3.1 (as of 5 September 2005)1 MHLW 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 Affairs 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 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 (Article 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 Manufacturing 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) Chapter 5 Manufacturing Control and Quality Control in Manufacturing Sites of In-Vitro Diagnostic Reagents Manufacturers, etc. (Article 80) Supplementary ProvisionsChapter 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 mutandis under Paragraph 5 of Article 19-2, and hereinafter referred to as such) o