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All MFDS Guidance (by Topic)

MFDS publishes official guidance documents (가이드라인) and notifications (고시) explaining how the Medical Devices Act and IVD Act are applied in practice.

Where to find guidance​

  • MFDS website: mfds.go.kr → 법령자료 (Legal resources) → 가이드라인 (Guidelines)
  • Korean Law Information Center: law.go.kr for 고시 (Notifications)

Major topic areas​

  • Pre-market: classification, 품목허가, STED, clinical evaluation, clinical trials
  • GMP: KGMP requirements, inspection checklists
  • Post-market: adverse event reporting, recalls, PMS
  • UDI-K: KIMS registration
  • Digital health: SaMD, AI/ML, cybersecurity
  • IVD-specific guidance under the IVD Act

Language​

Most MFDS guidance is in Korean only. Selected key documents have unofficial English translations. IMDRF-aligned documents sometimes have English source documents available from imdrf.org.

Major topic areas​

Device-type-specific guidance: MFDS publishes separate guidance for specific device categories (e.g., orthopaedic implants, cardiac devices, in vitro diagnostics) and by classification grade (Class I–IV). See 'Guidance by Device Type and Grade' for details on locating device-specific documents.