MDSAP · Basic · 14 min lesson
MDSAP and ISO 13485:2016 - the clause crosswalk and where MDSAP adds more
MDSAP AU P0002 Audit Approach (90 tasks, seven chapters), ISO 13485:2016 clauses 4 to 8, country-specific notes for Australia, Brazil, Canada, Japan and the United States
What you will learn
- Map the 90 tasks to ISO 13485:2016 clauses.
- Find the country-specific additions.
- Close gaps before the audit.
Key takeaways
- The Audit Approach has 90 tasks in seven chapters, and each task lists ISO 13485:2016 clauses and country regulations.
- Auditors cite the more specific clause, and documented means established, implemented and maintained.
- Chapters 2 and 4 and the sterile device annex add the most beyond ISO 13485.
- The FDA QMSR took effect on 2 February 2026 and the Audit Approach was revised in February 2026.
- Build a crosswalk, rate gaps, assign owners, close with evidence and verify by internal audit.
Free practice question
Tidewell's quality manager says the ISO 13485 certificate from the notified body is enough evidence for the MDSAP chapter on marketing authorization.
What is the best reply?
It is not enough; chapter 2 asks for authorizations and registrations in each market, which ISO 13485 clause 7.2.1 does not itself prove.
Correct. Chapter 2 of the MDSAP Audit Approach tests market evidence beyond the certificate under ISO 13485 clause 7.2.1.
It is enough because the chapter only checks the quality manual.
Not quite. Chapter 2 checks authorization and registration evidence, not the manual, in MDSAP.
It is enough if the distributor says so by email.
Not quite. An email claim is not objective evidence of clearance in the MDSAP audit of chapter 2.
It is enough for Australia only.
Not quite. Chapter 2 lists evidence for each participating jurisdiction, not just Australia, in MDSAP.
Key terms
- Audit Approach (AU P0002): The programme document that tells auditors the sequence, tasks and country notes for each audit process.
- audit task: One unit of audit work in a chapter, with ISO 13485 clauses, regulatory references and country notes.
- clause and regulation block: The part of each task that lists ISO 13485:2016 clauses and the matching regulatory references.
- crosswalk: A table mapping each audit task to clause, regulation, procedure, record, owner and gap rating.
- QMSR: The FDA Quality Management System Regulation, which incorporates ISO 13485:2016 into 21 CFR 820 from 2 February 2026.
- marketing authorization holder (Japan): The Japan-resident entity that files applications and notifications for devices (Audit Approach chapter 2).
- ARTG: The Australian Register of Therapeutic Goods, where a sponsor includes a device before supply (Audit Approach chapter 2).
- reportability decision: A recorded decision on whether a complaint or event must be reported to a regulator (ISO 13485 clause 8.2.3).
Official sources
- MDSAP AU P0002.007, MDSAP Audit Approach (FDA)
- MDSAP AU P0002.010, MDSAP Audit Approach (MDSAP programme site)
- MDSAP AU P0026, Certificate Document Requirements (FDA)
- NSF, MDSAP Audit Approach update: what changed and why it matters
Go further
The full lesson has narrated slides, more scenario questions with explained answers and a simulation.
Open the AcademyWatch on YouTubeIllustrative example. Educational only, not legal advice.