EMERGO BY UL SUMMARY OF KEY POINTS:

  • Japanese regulators extending participation in MDSAP through early 2020;
  • PMDA will continue recognizing MDSAP certificates for QMS compliance through the next year.

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

According to a notification (link in Japanese) from the Japanese Pharmaceutical and Medical Devices Agency, the decision to continue participation means MDSAP certificates will remain valid for Japanese quality management system requirements and audits through March 2020. The government has been determining whether to continue MDSAP participation on an annual basis since 2016.

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.

Learn more about MDSAP and QMS requirements at Emergo by UL:

  • MDSAP on-site training for medical device manufacturers
  • MDSAP internal and gap audits
  • Japan MHLW Ordinance 169 QMS compliance support
  • Webinar: Overview of the MDSAP certification process

AUTHOR

  • Stewart Eisenhart