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Medical Device Single Audit (MDSAP)

Standardizing how we audit medical devices on a global scale

The Medical Device Single Audit Program (MDSAP) is designed to allow a single audit for medical device manufacturers that is accepted in multiple regulatory jurisdictions. Led by various Regulatory Authorities (RA) worldwide, the initiative is aimed at boosting efficiency and safety through increased consistency. As an independent and recognized auditing organization, DEKRA performs audits within the MDSAP.

Why DEKRA for Auditing Medical Devices

  • Australia: The Therapeutics Goods Administration (TGA) will use an MDSAP audit report as part of the evidence in evaluating compliance with the Australian Conformity Assessment procedure
  • Brazil: The Brazilian National Health Surveillance Agency (ANVISA) will utilize the outcomes of the program, including the reports, to constitute important input into ANVISA’s pre-market and post-market assessment
  • Canada: HC will use an MDSAP audit and associated MDSAP certification to support medical device licensing for manufacturers intending to sell medical devices in Canada
  • USA: The USA’s Food and Drug Administration (FDA) will accept the MDSAP audit reports as a substitute for FDA routine inspections
  • Japan: Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) will use the MDSAP audit report to, e.g., exempt from inspections and substitute documents

How can we help you with Auditing Medical Devices?

Currently, the following countries participate in the program: Australia, Brazil, Canada, Japan and the USA. At DEKRA, we perform MDSAP audits and keep our customers up to date about relevant developments concerning the program. Our experts have extensive knowledge of and experience with MDSAP and the requirements of the Regulatory Authorities that participate in the program: TGA in Australia, ANVISA in Brazil, Health Canada, MHLW and PMDA in Japan and FDA in the USA.