← All terms
CATEGORY: ORGANIZATIONS
MDSAP
The Medical Device Single Audit Program — allows a single audit of a medical device manufacturer's QMS to satisfy requirements of multiple participating regulatory authorities (FDA, Health Canada, TGA, ANVISA, MHLW/PMDA).
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
MDSAP allows one QMS audit to satisfy multiple participating authorities (e.g., FDA, Health Canada, TGA, ANVISA, MHLW/PMDA) reducing duplicate audits.
PROCESS / STEPS
- Confirm target markets participate and accept MDSAP for your needs.
- Select an AO and schedule audit against MDSAP audit model.
- Close nonconformities; use report as multi-market evidence package input.
EXAMPLES
- A manufacturer selling in US, Canada, and Australia may cover QMS evidence via one MDSAP audit cycle.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to MDSAP across 27 authorities in real time.
START FREE →