MHLW MO169 日本医疗器械质量管理体系要求 下载积分: 1000 内容提示: 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 ...
MHLW MO169 has transitioned MHLW Ministerial Ordinance 169 (MHLW MO169) was initially published in 2004 to ensure that Japanese medical device QMS requirements are harmonized with ISO13485:2003. On March 26, 2021, MHLW MO169 was revised to align with the updated ISO13485:2016, with a tran...
MO 169 与 ISO 13485:2003 基本一致(比较表,第 2 节)。但是,第 3 章包含您作为制造商和您的授权代表 (MAH) 必须遵守的附加要求。其中包括对保留期限和警惕性的要求,以及制造商和授权代表之间的沟通规则。 指定当地授权代表 作为国外制造商,您必须指定一名日本当地授权代表,称为营销授权持有人(MAH)。MAH 对您...
MHLW MO169 has transitioned MHLW Ministerial Ordinance 169 (MHLW MO169) was initially published in 2004 to ensure that Japanese medical device QMS requirements are harmonized with ISO13485:2003. On March 26, 2021, MHLW MO169 was revised to align with the updated ISO13485:2016, with a t...