Japan – Japanese regulators extend Medical Device Single Audit Program (MDSAP) pilot

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…