October 11, 2021
Japan’s Ministry of Health, Labour and Welfare (MHWL) has updated its processes and procedures for accepting quality management system (QMS) audit reports from medical device market registrants under the Medical Device Single Audit Program, or MDSAP.
A recent notification (link in Japanese) from the MHLW explains revised requirements from the ministry as well as the Pharmaceuticals and Medical Devices Agency (PMDA), which directly regulates medical devices in Japan, in terms of submitting QMS audit reports under the MDSAP for Japanese medical device market applicants and registrants.
Under MDSAP, regulators in Japan as well as the US, Canada, Brazil and Australia accept single quality system reports from device manufacturers in order to help streamline QMS compliance and market access. 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 acceptance requirements established in June 2016.