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GHTF (Global Harmonization Task Force)

Le prédécesseur de l'IMDRF, le GHTF était un groupe international volontaire d'autorités réglementaires travaillant à l'harmonisation de la réglementation des dispositifs médicaux.

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 Global Harmonization Task Force (GHTF) produced foundational guidance on device classification, QMS, clinical evidence, and vigilance. Though superseded organizationally by IMDRF, GHTF documents still influence many national frameworks.

PROCESS / STEPS

  1. Use GHTF/IMDRF guidance as a bridge when comparing multi-market requirements.
  2. Map legacy GHTF terms to current IMDRF documents for modern submissions.
  3. Avoid citing obsolete versions when regulators point to newer IMDRF texts.

EXAMPLES

  • Many APAC classification schemes still echo GHTF risk classes (A–D / I–IV patterns).

RELATED GUIDES & TOOLS

SOURCES

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TERMES CONNEXES

IMDRFMDSAP