On March 26, 2021, MHLW MO169 was revised to align with the updated ISO13485:2016, with a transition period of3 years for manufacturers.Visit the PMDA website. This means that the deadline for manufacturers to make this transition is March 25, 2024. If the transition has not been ...
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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 transition period of 3 years for...
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