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MDSAP AUDIT APPROACH

Maybe you are looking to be into the MDSAP program and to benefit for it. We want to provide you the latest guidance on the MDSAP Audit Approach. The Medical Device Single Audit Program allows an MDSAP recognized Auditing Organization to conduct a single regulatory audit of a medical device manufacturer that satisfies the relevant requirements of the regulatory authorities participating in the program.

International partners that are participating in the MDSAP include:

  • MDSAP Members

    • Therapeutic Goods Administration of Australia

    • Brazil’s Agência Nacional de Vigilância Sanitária

    • Health Canada

    • Japan’s Ministry of Health, Labour and Welfare, and the Japanese Pharmaceuticals and Medical Devices Agency

    • U.S. Food and Drug Administration


  • MDSAP Official Observers:

    • European Union (EU)

    • United Kingdom's Medicines and Healthcare products Regulatory Agency (MHRA)

    • The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs) Programme


  • MDSAP Affiliate Members: (New)

    • Argentina's National Administration of Drugs, Foods and Medical Devices (ANMAT)

    • Republic of Korea's Ministry of Food and Drug Safety

    • Singapore's Health Sciences Authority (HSA)


Based on its evaluation of the MDSAP Final Pilot Report, the MDSAP Regulatory Authority Council (the international MDSAP governing body) determined that the MDSAP Pilot had satisfactorily demonstrated the viability of the Medical Device Single Audit Program.


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MDSAP Audit
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