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IMDRF
国际医疗器械监管者论坛——自愿参与的医疗器械监管机构团体，致力于协调监管实践。成员包括FDA、EMA、加拿大卫生部、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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