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CATEGORY: QUALITY SYSTEMS
Korean Good Manufacturing Practice (KGMP)
South Korea's manufacturing quality standard for medical devices, administered by MFDS. KGMP compliance is mandatory for all medical device manufacturers seeking Korean market access.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · 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
Track regulatory signals related to Korean Good Manufacturing Practice (KGMP) across 27 authorities in real time.
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