MDSAP · Expert · 14 min lesson
Regulatory authority exchange - how FDA, Health Canada, ANVISA, PMDA and TGA use reports, special audits and escalations
MDSAP AU P0027 section 5, AU P0019, AU P0002 audit approach (special and unannounced audits), AU F0019.1 section 3, MDSAP program FAQ
What you will learn
- Explain information exchange among regulators.
- Handle special and unannounced audits.
- Prepare for regulator questions.
Key takeaways
- Each participating regulator (TGA, ANVISA, Health Canada, MHLW/PMDA, FDA) uses the audit deliverables independently under its own law.
- The auditing organization sends the package; 5-day notice for grade 5 or more than two grade 4; package at D0+45 or D0+90; updated reports within 10 calendar days of a request.
- Reports can replace routine inspections in several markets but not for-cause, follow-up or approval inspections.
- Special audits are extraordinary and focused; unannounced audits are a subset and are recorded as such in report section 3.
- Be ready: one owner, a request log, an evidence index, version control and facts consistent across jurisdictions; never alter records.
Free practice question
Norvik's auditing organization receives a regulator request for updated nonconformity reports for the last audit.
How long does the organization have to provide them?
Ten calendar days from the request.
Correct. MDSAP AU P0027 requires updated NC reports within 10 calendar days of an MDSAP regulatory authority request.
Five working days from D0.
Not quite. The 5 working days of MDSAP AU P0027 apply to the early notice from D0, not to a request for updated reports.
Ninety calendar days from the request.
Not quite. The 90 days in MDSAP AU P0027 are counted from D0 for the complete package, not from a later request.
There is no deadline.
Not quite. MDSAP AU P0027 sets a 10 calendar day limit for updated reports on request, so the deadline exists.
Key terms
- Regulatory Authority Council: The governing body of MDSAP made up of senior managers from the participating regulators.
- special audit: An extraordinary, focused audit outside the planned three-year cycle.
- unannounced audit: A type of special audit that regulators require when high-grade nonconformities are detected.
- 5-day notice: Early notice to regulators within 5 working days of D0 for a grade 5 or more than two grade 4 findings.
- D0: The audit end date from which post-audit timelines are counted.
- regulatory exchange platform: The secure system through which the auditing organization sends packages to regulators.
Official sources
- MDSAP Frequently Asked Questions (FDA)
- MDSAP AU P0002 MDSAP Audit Approach (FDA)
- MDSAP AU P0027 Post Audit Activities and Timeline Policy
- MDSAP AU P0019 Medical Device Regulatory Audit Reports Policy (FDA)
- MDSAP AU G0019.3 Medical Device Regulatory Audit Report Form Guidelines (FDA)
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.