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All MFDS Guidance (by Topic)

MFDS publishes official guidance documents (κ°€μ΄λ“œλΌμΈ) and notifications (κ³ μ‹œ) explaining how the Medical Devices Act and IVD Act are applied in practice.

Where to find guidance​

  • MFDS website: mfds.go.kr β†’ λ²•λ Ήμžλ£Œ (Legal resources) β†’ κ°€μ΄λ“œλΌμΈ (Guidelines)
  • Korean Law Information Center: law.go.kr for κ³ μ‹œ (Notifications)

Major topic areas​

  • Pre-market: classification, ν’ˆλͺ©ν—ˆκ°€, 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.