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CATEGORY: ORGANIZATIONS
IMDRF
The International Medical Device Regulators Forum — a voluntary group of medical device regulators working to harmonize regulatory practices. IMDRF members include FDA, EMA, Health Canada, TGA, MHLW/PMDA, NMPA, ANVISA, MFDS, and HSA.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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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