Dec 5, 2021

A new notification from Japanese medical device market regulators have clarified procedures whereby manufacturers may use Medical Device Single Audit Program (MDSAP) reports to support quality management system (QMS) regulatory compliance claims.

The Pharmaceutical and Medical Devices Agency’s (PMDA) notification (link in Japanese) identifies which MDSAP documents to include in QMS conformity survey submissions from registered manufacturing facilities, along with associated application and submission fees. Japan as well as the US, Canada, Brazil and Australia currently participate in MDSAP, which allows medical device manufacturers to use a single QMS audit report to satisfy all participating market regulators’ quality system compliance requirements.

Japanese regulators will implement procedures covered in the new notification starting April 1, 2022, when full-scale PMDA acceptance of MDSAP audit reports will also begin.

Learn more about MDSAP and Japanese PMDA registration for medical devices:

  • MDSAP internal and gap audits for medical device companies
  • On-site MDSAP training for device manufacturers
  • Japan PMDA registration and approval consulting
  • Japan MHLW Ordinance 169 quality system compliance support
  • Whitepaper: Transitioning to MDSAP for QMS compliance

Author

  • Stewart Eisenhart

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