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Regulatory Framework Overview

Legislative hierarchy​

Medical Devices Act (μ˜λ£ŒκΈ°κΈ°λ²•)          IVD Act (μ²΄μ™Έμ§„λ‹¨μ˜λ£ŒκΈ°κΈ°λ²•)
         β”‚                                         β”‚
  Enforcement Decree (μ‹œν–‰λ Ή)             Enforcement Decree
         β”‚                                         β”‚
  Enforcement Rules (μ‹œν–‰κ·œμΉ™)            Enforcement Rules
         β”‚                                         β”‚
      MFDS Notifications (κ³ μ‹œ) & Guidelines (κ°€μ΄λ“œλΌμΈ)

Key regulatory stages​

StageRequirement
ClassificationGrade I–IV (devices) or A–D (IVDs)
Business licensingManufacturer / importer licence
Pre-marketGrade III/IV β†’ ν’ˆλͺ©ν—ˆκ°€; Grade I/II β†’ ν’ˆλͺ©μ‹ κ³ 
GMPKGMP certification (domestic) or foreign GMP recognition
UDI-KRegistration in KIMS database
Post-marketAdverse event reporting, PMS, re-examination, labelling

Critical Korean difference​

KGMP certification is a prerequisite for ν’ˆλͺ©ν—ˆκ°€ β€” no GMP certificate = no approval.