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GHTF (全球協調工作組)
IMDRF的前身，GHTF是致力於協調醫療器材監管的自願性國際監管機構團體。GHTF發布了關於分類、QMS、臨床證據和警戒的基礎指南文件。
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 Though superseded organizationally by IMDRF, GHTF documents still influence many national frameworks.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
- Use GHTF/IMDRF guidance as a bridge when comparing multi-market requirements.
- Map legacy GHTF terms to current IMDRF documents for modern submissions.
- 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
Track regulatory signals related to GHTF (全球協調工作組) across 27 authorities in real time.
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