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.

Why it matters

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.

Common pitfalls

•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.

Sources

FDA MDSAP · FDA
FDA, Medical Device Single Audit Program (MDSAP) · FDA
MDIC Case for Quality · MDIC

Open full page

Select term B to compare.

Why compare MedTech terms side by side?

MedTech terminology is full of pairs that look interchangeable but carry very different regulatory, clinical, and commercial consequences. Picking the wrong framework, pathway, or standard early in a project can add months to a submission, invalidate clinical evidence, or trigger an audit finding. Side-by-side comparison is the fastest way to surface those differences before they become costly mistakes.

Each comparison on this page pulls from the same vendor-neutral, sourced definitions used throughout the MedTech Terms glossary. You see the one-line summary, the formal definition, why it matters in practice, common pitfalls, and the primary sources (FDA guidance, EU MDR/IVDR articles, ISO/IEC standards, MDCG documents, IMDRF principles) that back each entry. That makes the comparison defensible in regulatory strategy memos, design reviews, and submission narratives.

Common comparison patterns

Regulatory pathway choice - 510(k) vs PMA, 510(k) vs De Novo, Abbreviated vs Special 510(k).
Quality systems - QSR vs ISO 13485, QMSR vs QSR.
Software classification - SaMD vs SiMD, Locked vs adaptive AI.
EU frameworks - MDR vs IVDR, CE Mark vs UKCA.
Cybersecurity artifacts - SPDX vs CycloneDX SBOM, CVE vs CVSS.
Post-market actions - Recall vs field action, Removal vs correction.

How to use this tool

Pick term A and term B from the dropdowns, or click a preset above. The URL updates with both slugs so you can bookmark or share the exact comparison with a colleague, a notified body reviewer, or your regulatory consultant. Click Open full page on either side for the complete entry, including FAQs, related terms, and the full citation list. If you are not sure which term to start with, browse the Categories view or the A-Z index.

MedTech Terms is a vendor-neutral community resource sponsored by Blue Goat Cyber. Definitions are written for educational use and are not legal or regulatory advice.