Current Edition Checked October 24, 2026
Five participating authorities — Australia’s TGA, Brazil’s ANVISA, Health Canada, Japan’s MHLW and PMDA, and the US FDA — with the EU, Singapore’s HSA, the UK MHRA and WHO prequalification as observers, and further affiliate members.
What It Covers
One audit of a device manufacturer’s quality system, by a recognized auditing organization, that each participating regulator can use in place of, or alongside, its own inspection.
Who It Applies To
Manufacturers selling into two or more participating markets. Health Canada requires MDSAP certification for device licensing.
Key Requirements
- An audit against ISO 13485:2016 plus the requirements of each participating jurisdiction you sell into.
- A three-year cycle: initial certification audit, annual surveillance audits, recertification.
- Findings graded on the MDSAP scale, with reporting deadlines for remediation.
- FDA accepts MDSAP audit reports as a substitute for routine inspections.
What an Auditor Asks to See
- Evidence of each country’s requirements — registration, reporting, labeling — not only ISO 13485.
- Responses to graded nonconformities within the program’s deadlines.
Where Systems Fall Short
- Country-specific requirements missing for a market added since the last audit.
- Nonconformity responses late or without evidence.
How QES Helps
A mock audit run on the MDSAP model, country requirements included.
Related Standards
Sources. TÜV SÜD — Medical Device Single Audit Program (opens in a new tab). Status checked October 24, 2026. This page summarizes MDSAP; it does not reproduce or replace it. Buy the standard from its publisher, or read the regulation in its official text, before relying on a detail. Not legal advice.