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 ...
Chapter one of MO 169 establishes the foundation needed for manufacturers to gain entry into the Japanese market for their products. Complying with all of the requirements delineated throughout MO 169 is not only the expectation, it is mandated by law. Similar to other device regulations and stan...
质量管理体系要求可在 2014 年修订的第 169 号部令 (MO 169)中找到。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。 Step 02:指定当地授权代表 作...
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:
Here at BSI, we want to ensure that your transition to MHLW MO169 runs as smoothly as possible – and we are ready to start this process. Transition audits will be conducted at your regularly scheduled annual assessment – either at your surveillance or recertification audit. This ensures ...
质量管理体系要求可在 2014 年修订的第 169 号部令 (MO 169)中找到。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。