Regulatory Framework Overview

Legislative hierarchy

Medical Devices Act (의료기기법)          IVD Act (체외진단의료기기법)
         │                                         │
  Enforcement Decree (시행령)             Enforcement Decree
         │                                         │
  Enforcement Rules (시행규칙)            Enforcement Rules
         │                                         │
      MFDS Notifications (고시) & Guidelines (가이드라인)

Key regulatory stages

Stage	Requirement
Classification	Grade I–IV (devices) or A–D (IVDs)
Business licensing	Manufacturer / importer licence
Pre-market	Grade III/IV → 품목허가; Grade I/II → 품목신고
GMP	KGMP certification (domestic) or foreign GMP recognition
UDI-K	Registration in KIMS database
Post-market	Adverse event reporting, PMS, re-examination, labelling

Critical Korean difference

KGMP certification is a prerequisite for 품목허가 — no GMP certificate = no approval.

Related pages

• Who needs to comply? · Lifecycle

Foreign manufacturer representation: Foreign manufacturers must appoint a Korean agent (한국 대리인) — typically the importer — to serve as the official representative for all regulatory communications and submissions to MFDS during the approval and post-market phases