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MDSAP

About MDSAP

 The Medical Device Single Audit Program (MDSAP) is intended to allow MDSAP recognized Auditing Organizations to conduct a single audit of a medical device manufacturer that will satisfy the relevant requirements of the medical device regulatory authorities participating in the program.

 Japan's Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has been participating to the program since June 2015.

 International partners that are participating in the MDSAP include:

  • Therapeutic Goods Administration of Australia
  • Brazil's Agência Nacional de Vigilância Sanitária
  • Health Canada
  • U.S. Food and Drug Administration
 
  • The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme and the European Union (EU) are Official Observers
 

Trial acceptance of MDSAP Audit Reports

  PMDA will accept MDSAP audit reports as a trial, when it performs QMS compliance inspections  (see details).

Notifications from MDSAP

 Reference

JCN 3010005007409

Shin-Kasumigaseki Building, 3-3-2 Kasumigaseki, Chiyoda-ku, Tokyo 100-0013 Japan

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