What MDSAP is
The IMDRF program behind the single audit — five regulators, one AO, ISO 13485 plus country clauses.
Free field guide · PDF
MDSAP Single Audit Program2026 Field Guide
One audit, five regulators, and the 3-year cycle — with the MDSAP practice you need.
- One audit, five markets
- 5 regulators
- Audit cycle
- 3-year
- Audit-cost reduction
- ~20%
Sourced from regulatory guidance and verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — regulatory guidance and verified 2026 publications.
The 3-year cycle
Initial certification, two surveillance audits, recertification — 4–6 days of auditing, and Canada's mandate for Class II–IV.
The Brazil lever
ANVISA grants B-GMP certificates from your MDSAP report — and extends them to 4 years. One program, two continents.
Sources & scope
- simplerqms.com, Medical Device Single Audit Program (MDSAP), updated 23 Jul 2026.
- mdr.guide, Medical Device Single Audit Program | Quick Guide.
- meddeviceguide.com, MDSAP Audit: The Complete Guide.
- mddionline.com, How to Navigate the Triad of Audits in Medical Device Compliance.
This guide is market-access intelligence, not regulatory or legal advice. MDSAP rules, audit practice, and country requirements change — professional review is required before business use.
Market Access Strategy Session
One audit for five markets? Start with the full picture.
A Market Access Strategy Session maps your MDSAP route — jurisdiction scoping, audit-hosting readiness, and the Brazil B-GMP path.
Professional review is required before business use.
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