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CATÉGORIE: QUALITY SYSTEMS
Bonnes pratiques de fabrication coréennes (KGMP)
La norme coréenne de qualité de fabrication pour les dispositifs médicaux, administrée par le MFDS.
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
KGMP refers to Korea’s Good Manufacturing Practice requirements for medical devices under MFDS oversight. Manufacturers placing devices on the Korean market must meet KGMP certification expectations via recognized bodies.
PROCESS / STEPS
- Determine device class and KGMP applicability for the manufacturer sites.
- Prepare QMS documentation aligned with MFDS KGMP requirements (often ISO 13485-based with local specifics).
- Undergo KGMP audit/certification through an authorized organization.
- Maintain surveillance audits and change notifications.
EXAMPLES
- Foreign manufacturers often coordinate KGMP with a Korean license holder / MAH arrangements.
RELATED GUIDES & TOOLS
SOURCES
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