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...
Prior to the MHLW joining MDSAP as a participating regulator, Japanese market registration required compliance to MHLW Ordinance 169 for QMS compliance for manufacturers. The latest MHLW notification will come into effect April 1, 2022, and will replace the ministry’s notification regarding MDSAP ...
Ministerial Ordinance 169 is the main regulation specifically listing QMS requirements. Physical on-site audits for QMS compliance are required for some Class III and most Class IV medical devices. Do QMS audits only cover manufacturing facilities? QMS audits also cover other facilities besides the ...
If your device's code does not exist, products must go through a new device pathway, and classification is determined by risk according to the classification rules in Yakusyokuhatsu No. 0720022. However, final determination of your device classification would be made by the MHLW. ...
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...