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類別: ORGANIZATIONS
IMDRF
國際醫療器材監管者論壇——自願參與的醫療器材監管機構團體，致力於協調監管實踐。成員包括FDA、EMA、加拿大衛生部、TGA、PMDA、NMPA等。
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
The International Medical Device Regulators Forum harmonizes regulatory practices among major authorities (FDA, EU members via representation, Health Canada, TGA, PMDA, NMPA, ANVISA, and others).
PROCESS / STEPS
- Track IMDRF guidance relevant to SaMD, UDI, and clinical evidence.
- Use IMDRF documents to align multi-market dossiers.
- Map national deviations still required despite harmonization.
EXAMPLES
- SaMD risk categorization guidance is a commonly cited IMDRF work product.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to IMDRF across 27 authorities in real time.
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