MDSAP · Expert · 14 min lesson
Change and transition - QMSR 2026, Audit Approach revisions, RDC 665, MO 169 and keeping a multi-regulation QMS current
FDA QMSR (21 CFR Part 820, effective 2 February 2026), MDSAP AU P0002 revisions 009, 010 and 011, ANVISA RDC 665/2022, MHLW Ministerial Ordinance 169 (2021 amendment), ISO 13485:2016 clauses 4.1.4, 4.2.4, 5.6.2 and 6.2
What you will learn
- Track regulatory change in the five MDSAP jurisdictions and in the MDSAP Audit Approach, with a named owner, a source list and a change log.
- Run a documented gap analysis for a change such as the FDA QMSR, the Audit Approach revisions, Brazil RDC 665/2022 or Japan MO 169.
- Update procedures and training before the effective date, and show an auditor the evidence from detection to effectiveness check.
Key takeaways
- The QMSR took effect on 2 February 2026 and incorporates ISO 13485:2016, but Parts 803, 806, 807 and 830 are separate FDA requirements that still apply.
- The MDSAP Audit Approach has moved from revision 009 (August 2024) to 010 (document date 6 February 2026) and 011 (3 August 2026); confirm with your auditing organization which version applies to your audit.
- RDC 665/2022 (in force 2 May 2022) consolidated RDC 16/2013 and IN 8/2013 without new requirements, and Japan requires only the 2021 amended MO 169 since 25 March 2024.
- Clause 4.1.4 requires QMS changes to be evaluated for impact on the QMS and on the devices, and clause 5.6.2 puts new or revised regulatory requirements into management review.
- A traceable chain of source, owner, gap analysis, updated procedure, completed training and effectiveness check is what the auditor asks to see.
Free practice question
Calder's quality manager reads an industry blog saying the QMSR changes everything. She starts rewriting all sixty procedures that afternoon.
What should have happened first?
Rewrite all sixty procedures, because blogs are reliable enough.
Not quite. A blog is secondary; clause 4.1.4 expects evaluation of impact, which a blanket rewrite does not provide.
Read the FDA primary text, confirm the effective date and map the change to affected procedures before rewriting.
Correct. The FDA QMSR page is the primary source, and clause 4.1.4 expects changes to be evaluated before they are made.
Ask the auditing organization to rewrite the procedures.
Not quite. The manufacturer owns its procedures under ISO 13485 clause 4.2.1; the auditing organization only audits them.
Do nothing until the next MDSAP audit is announced.
Not quite. Waiting ignores the change monitoring that ISO 13485 clause 5.6.2 expects to reach management review.
Key terms
- Quality Management System Regulation (QMSR): The amended FDA 21 CFR Part 820, effective 2 February 2026, which incorporates ISO 13485:2016 by reference.
- MDSAP Audit Approach (AU P0002): The MDSAP document that tells auditors which tasks to audit in each chapter; revision 011 is dated 3 August 2026.
- RDC 665/2022: The ANVISA resolution on good manufacturing and distribution practices for devices, consolidating RDC 16/2013 and IN 8/2013, in force 2 May 2022.
- MHLW Ministerial Ordinance 169 (MO 169): The Japanese QMS ordinance, amended on 26 March 2021 to match ISO 13485:2016, with compliance required by 25 March 2024.
- gap analysis: A documented comparison of a new requirement with current procedures and practice, with a decision, owner and date for each gap.
- regulatory change log: The record of each regulatory change: source, effective date, owner, impact decision, actions, training and effectiveness check.
Official sources
- FDA, Quality Management System Regulation (QMSR)
- MDSAP AU P0002.011 MDSAP Audit Approach (mdsap.global, July 2026 posting)
- MDSAP AU P0002.010 MDSAP Audit Approach (mdsap.global, February 2026 posting)
- MDSAP AU P0002.009 MDSAP Audit Approach (FDA)
- ANVISA, RDC 665 de 2022
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.