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 ...
日本后生劳动省省令169号(MO 169)规定了医疗器械和体外诊断器械的质量管理体系要求。MO 169以ISO 13485为基础,并结合日本情况,做了适当调整,2004年首次发布,后经过了多次修订。最新的MO 169内容如下:
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...
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 trans...