Essentially, chapter one (Article 1) establishes the foundation for MO 169 and the requirement to comply, as delineated by the Japanese Pharmaceutical Affairs Law (JPAL) of 1960. Additionally, similar to other regulations and standards, MO 169 (Article 2) contains its own set of terms and def...
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 ...
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...