Medical Device Single Audit Program (MDSAP)
MDSAP allows a recognized auditing organization to conduct one regulatory audit addressing the relevant quality system requirements of participating medical device regulators. It does not replace product registration or every type of regulatory inspection.
What is MDSAP?
The Medical Device Single Audit Program enables a recognized Auditing Organization to perform one regulatory audit that addresses the relevant requirements of multiple participating jurisdictions.
The audit evaluates the manufacturer’s quality management system against ISO 13485 and applicable country-specific requirements. MDSAP does not provide one global product approval.
Which regulators participate in MDSAP?
As of July 2026, the principal MDSAP members are Australia’s TGA, Brazil’s ANVISA, Health Canada, Japan’s MHLW and PMDA, and the U.S. FDA.
MDSAP also has official observers and affiliate members. Those categories should not be described as equivalent to full regulatory members, because their participation and use of audit outcomes differ.
Is MDSAP mandatory?
The answer depends on the market. Canada generally requires manufacturers of Class II, III and IV devices to hold an appropriate MDSAP-issued quality system certificate for medical device licensing.
Other member regulators use MDSAP differently. The FDA may accept an MDSAP audit report as a substitute for certain routine inspections, but it retains its inspection and enforcement authority. Manufacturers should confirm the rules for each jurisdiction.
How is MDSAP different from ISO 13485 certification?
A conventional ISO 13485 audit evaluates conformity with the quality management system standard. An MDSAP audit uses ISO 13485 as its foundation and adds applicable regulatory requirements from participating countries.
An ISO 13485 certificate is therefore not automatically an MDSAP certificate. Likewise, an MDSAP certificate does not authorize a particular device for sale.
Who can conduct an MDSAP audit?
Only an Auditing Organization authorized or recognized through the MDSAP process can conduct an official MDSAP regulatory audit. Manufacturers should verify the organization’s current status and relevant scope before contracting.
MDSAP can support quality-system strategies for Canada, Australia, Brazil and the United States. Product registration, local representation, labeling and post-market obligations remain separate.
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