Tentative translation of MHLW MO 169 Chapter 3, as revised in 2021 Note: 1) This English document is only for reference purpose. In case of any discrepancies, the Japanese text shall prevail. 2) The requirements of MHLW MO 169 are applied to both the Marketing Authorization Holder etc. and the person operating the Registered Manufacturing Site (hereafter RMS). In this document the requirements are stipulated as the requirements for the Marketing Authorization Holder etc. Meanwhile, the requirements must be paraphrased as appropriate, when they are applied to RMS. 3) Article 69 to Article 72-3 are applied only to the Marketing Authorization Holder etc. (These requirements are not applied to RMS.). 4) Article 65, which was included in the chapter 3 of the previous version of the ordinance, is deleted in this version. Hence, there is no “Article 65” in this version. Chapter 3 Additional Requirements Regarding Manufacturing Control and Quality Control of Medical Devices, etc. (Additional Requirements Regarding Quality Management System) Article 66 (1) The Marketing Authorization Holder etc. shall establish, document, implement the quality management system pursuant to the provisions of Chapter 3 to Chapter 5-2 inclusive (limited to the provisions that shall apply pursuant to the provisions of Article 3, hereinafter the same in this article) as well as the provisions of Chapter 2 and also maintain its effectiveness. (2) The Marketing Authorization Holder etc. shall manage processes pursuant to the provisions of Chapter 3 to Chapter 5-2 inclusive, as well as the provisions of Chapter 2. (3) The Marketing Authorization Holder etc. shall describe the procedures and records (specified in each item of Article 6 as well as Chapter 3 to Chapter 5-2) in the documents related to the quality management system. (Retention Period of Quality Management System Documents) Article 67 (1) The Marketing Authorization Holder etc. shall retain the quality management system documents or their copies for the following periods (5 years for the documents for training) from the date of obsolete (see Article 8(4)) Proviso: This provision shall not apply to the quality management documents used for the manufacturing or testing of the products when they are maintained to be available for the period specified in the Article 68. (i) 15 years for the specially designated maintenance control required medical devices [one year plus the shelf life for the products of which the shelf life or the expiry date (hereinafter simply referred to as the "shelf life") plus one year exceeds 15 years] (ii) 5 years for the medical devices, etc. other than the specially designated maintenance control required medical devices (one year plus the shelf life for the products of which the shelf life plus one year exceeds 5 years). (Retention Period of Records) Article 68 (1) The Marketing Authorization Holder etc. shall retain the records specified under Article 9(1) or in this chapter for the following periods (5 years for the records of the training) from the date of creation. (i) 15 years for the specially designated maintenance control required medical devices (one year plus the shelf life for the products of which the shelf life plus one year exceeds 15 years) (ii) 5 years for the medical devices, etc. other than the specially designated maintenance control required medical devices (one year plus the shelf life for the products of which the shelf life plus one year exceeds 5 years). (Reporting Adverse Events, etc.) Article 69 The Marketing Authorization Holder etc. shall make all the facilities and the relevant registered manufacturing sites pursuant to the provisions of Article 23-2-3(1) or Article 23-2-4(1) of the PMDA Act (hereinafter referred to as the “Registered Manufacturing Site”), document the procedure to notify The Marketing Authorization Holder etc. of the matters specified in the items of Article 228-20(1) and 228-20(2) of the Enforcement Regulations concerning the products when the facilities and relevant Registered Manufacturing Sites recognize the matters concerned. (Relationship with Good Vigilance Practice (GVP)) Article 70 The Marketing Authorization Holder etc. shall perform the duties related to post-marketing safety control of the products pursuant to the provision of the Ordinance on the Standards for PostMarketing Safety Control of Drug, Quasi-Drug, Cosmetics and Medical Devices and Regenerative and Cellular Therapy Products, Gene Therapy Pr

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