Medical Device Single Audit Program
Single audit of a manufacturer's QMS satisfying multiple participating regulators.
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. MDSAP audits are performed by recognized auditing organizations against ISO 13485 plus the specific requirements of each participating authority. A three-year audit cycle includes an initial certification audit, annual surveillance audits and a recertification audit. Health Canada requires MDSAP for licensing, and FDA accepts MDSAP audit reports as a substitute for routine inspections. The EU participates as an observer, not a member.What this means in practice
MDSAP was developed by IMDRF and operationalized by the five participating regulators: US FDA, Health Canada, Brazil ANVISA, Australia TGA, and Japan MHLW/PMDA. Health Canada requires MDSAP for medical device licensure (mandatory since 2019). FDA accepts MDSAP audit reports in lieu of routine surveillance inspections (though for-cause and pre-approval inspections still occur). Audits are conducted by MDSAP-authorized Auditing Organizations against ISO 13485:2016 plus country-specific requirements documented in the MDSAP Audit Model. Audit duration is calculated from a formula in the MDSAP Companion Document based on employee count and site complexity.Examples
- A mid-size Class II manufacturer replacing separate FDA, Health Canada, and TGA audits with a single MDSAP audit cycle, saving roughly 15 audit-days per year.
- A contract manufacturer maintaining MDSAP certification to demonstrate to customers that its QMS satisfies five major regulators without additional audits.
- •Assuming MDSAP replaces all FDA inspections. Pre-approval, for-cause, and Bioresearch Monitoring inspections are outside the MDSAP scope.
- •Under-scoping. MDSAP scope must cover all sites and processes relevant to devices marketed in participating countries; missed scope triggers gaps at surveillance audits.
- •Poor preparation for country-specific requirements. Each regulator layers requirements (e.g. Brazil GMP, Japan JPAL) on top of ISO 13485 that are frequently missed.
- •Treating the initial certification audit as a one-off. MDSAP requires annual surveillance audits and a three-year recertification cycle with sample-based coverage.
Frequently asked questions
Cross-references
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsSystematic process to investigate and resolve quality issues and prevent recurrence.
FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.
FDA's current good manufacturing practice (cGMP) requirements for medical devices.
International standard for medical device quality management systems.
More in Quality & Risk
· Same categoryAbility of a material to perform with an appropriate host response in a specific application.
Verification step confirming a corrective or preventive action actually fixed the problem.
Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance.
Process for receiving, evaluating, and responding to device complaints.
Where this term appears across MedTech Terms.
Latest in MedTech
Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1FDA MDSAPTier 2 VerifiedFDAfda.gov
- 2FDA, Medical Device Single Audit Program (MDSAP)Tier 2 UncheckedFDAfda.gov
- 3MDIC Case for QualityTier 4 VerifiedMDICmdic.org
Inline markers like [1] jump to the matching reference above.