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Medical Device Single Audit Program (MDSAP)

Date: 25 Feb 2019

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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:

  • Therapeutic Goods Administration of Australia (TGA)

  • Brazil’s Agência Nacional de Vigilância Sanitária (ANVIS)

  • Health Canada

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

  • US's Food & Drug Adminstration (FDA)

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The World Health Organization (WHO) Prequalification of In Vitro Diagnostics (IVDs)Programme and the European Union (EU) are Official Observer.

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