Healthcare, Industry News, Medical Devices, Regulatory Affairs

MHLW may extend participation in MDSAP through early 2020

The Japanese Ministry of Health, Labor and Welfare (MHLW) is extending the country’s participation in the Medical Device Single Audit Program through early 2020.

According to a recent notification from the Japanese Pharmaceutical and Medical Devices Agency (PMDA), the decision to continue participation means MDSAP certificates will remain valid for Japanese quality management system requirements and audits through March 2020.

The MHLW’s decision to maintain participation in MDSAP helps ensure continuity of the program, which allows medical device manufacturers to meet quality requirements across Japan, the US, Canada, Brazil and Australia using a single certification.

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