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MDSAP

醫療器材單一審核計畫——允許對醫療器材製造商QMS進行單次審核,以滿足多個參與監管機構(FDA、加拿大衛生部、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

  1. Confirm target markets participate and accept MDSAP for your needs.
  2. Select an AO and schedule audit against MDSAP audit model.
  3. 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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