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    Quality & RiskQuality SystemGlobal MarketsMDSAP

    Medical Device Single Audit Program

    Single audit of a manufacturer's QMS satisfying multiple participating regulators.

    Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

    Definition

    MDSAP allows a single regulatory audit of a medical device manufacturer's QMS that satisfies the requirements of multiple participating regulatory authorities, including the U.S. FDA, Health Canada, ANVISA, TGA, and PMDA.

    What this means in practice

    Health Canada requires MDSAP for licensure. FDA accepts MDSAP audit reports in lieu of routine surveillance inspections.

    Cross-references

    Primary references

    3 sources
    Link health: 2 verified 1 bot-blocked· last checked 2026-05-09
    FDA·2MDIC·1
    1. 1
      FDA MDSAP
      Bot-blocked
      FDAfda.gov
    2. 2
      MDIC Case for Quality
      Verified
      MDICmdic.org
    3. 3
      FDA - Quality Systems
      Verified
      FDAfda.gov

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