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 ...
the PMDA is more likely to visit the foreign facilities in person. Japanese QMS standards are closely based on ISO 13485 standards, but have a few distinct differences. Ministerial Ordinance 169 is the main regulation specifically listing QMS requirements. Physical on-site audits for QMS compliance...
japan-mhlw-ordinance-2-english Tentative translation ver. 2.9 (as of 5 September 2005)1 MHW Ministerial Ordinance No. 2, 1961 Amended by: MHW Ministerial Ordinance No.47, 1964; MHW Ministerial Ordinance No.21, 1968; MHW Ministerial Ordinance No.32, 1980; MHW Ministerial Ordinance No.35, ...
As part of the approval process, medical device manufacturers must: Comply withMHLW Ordinance No. 169related to quality management systems Appoint an in-country representative (MAH/D-MAH) Register design and manufacturing facilities, among other requirements ...
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...