Tentative translation of MHLW MO 169 revid in 2014, Chapter 3
（Note)
（1）This English document is only for reference purpo. In ca of any discrepancy, the Japane text shall prevail.
（2）The requirements of MHLW MO 169 are applied to both the Marketing Authorization Holder and the person operating the Registered Manufacturing Site. In this document the requirements are stipulated as the requirements for the Marketing Authorization Holder. Meanwhile, when they are applied to the Registered Manufacturing Site, the requirements must be paraphrad, as appropriate.
（3）The requirements from Article 69 to Article 72-3 shall be applied only to the Marketing Authorization Holder. (They ae not applied to the person operating the Registered Manufacturing Site.)暮眼蝶
Chapter 3 Additional Requirements Regarding Manufacturing Control and Quality
口红制作
Control of Medical Devices, etc.
(Quality Management System of Registered Manufacturing Site)
Article 65
In ca that the business facility to which the process specified in Article 5.4 are outsourced or the business facility of the supplier of the purchad products is the Registered Manufacturing Site, the Marketing Authorization Holder shall perform necessary verification about that the person operating the Registered Manufacturing. site performs the manufacturing control and quality control bad on the appropriate quality management system.
图解麻衣神相
(Additional Requirements Regarding Quality Management System)信用卡还款方式
Article 66
1) The Marketing Authorization Holder shall establish, document, implement the quality m
anagement system pursuant to the provisions of Chapter 3 to Chapter inclusive (limited to the provisions that shall apply pursuant to the provisions of Article
, hereinafter the same in this article) as well as the provisions of Chapter 2 and also maintain its effectiveness.
2) The Marketing Authorization Holder shall manage process pursuant to the provisions of Chapter 3 to Chapter 5 inclusive, as well as the provisions of Chapter 2.
(3) The Marketing Authorization Holder shall describe the procedures and records (specified in Article 6(1) as well as Chapter 3 to Chapter 5) in the documents related to the quality management system specified in Article 6(1).
(Retention Period of Quality Management System Documents)
Article 67
(1) The Marketing Authorization Holder shall retain the quality management system docu
ments or their copies for the following periods (6 years for the documents for training) from the date of obsolete (e Article 8(4)
Proviso: This provision shall not apply to the quality management documents ud 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
撒科打诨
(1) The Marketing Authorization Holder shall retain the records specified under Article l
9(1) or in this chapter for the following periods (5 years for the records of the training) from the date of creation.
撕名牌(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 or the products of which the shelf life plus one year exceeds 5 years).
霜降的诗句古诗(Reporting Adver Events, etc.)
Article 69
The Marketing Authorization Holder shall make all the facilities and relevant
Registered Manufacturing Sites establish and document the procedure to notify the
Marketing Authorization Holder of the matters specified in the items of Article 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))
