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IMDRF

Das International Medical Device Regulators Forum — eine freiwillige Gruppe von Medizinprodukte-Regulierungsbehörden zur Harmonisierung der Regulierungspraktiken.

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

  1. Track IMDRF guidance relevant to SaMD, UDI, and clinical evidence.
  2. Use IMDRF documents to align multi-market dossiers.
  3. 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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