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MDSAP
医疗器械单一审核计划——允许对医疗器械制造商QMS进行单次审核，以满足多个参与监管机构（FDA、加拿大卫生部、TGA、ANVISA、PMDA）的要求。
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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.
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