Lifecycle of a Medical Device in Korea

Regulatory journey

1. Scope determination — Medical Devices Act or IVD Act?
2. Classification — Grade I/II/III/IV (or A/B/C/D for IVDs)
3. Business licensing — manufacturer licence or importer licence
4. KGMP certification — domestic on-site inspection or foreign GMP recognition
5. Technical documentation (STED) — device description, testing, risk, clinical data
6. Pre-market submission
   ├─ Grade III/IV: 품목허가 (Marketing Authorization)
   └─ Grade I/II:  품목신고 (Notification)
7. UDI-K registration in KIMS
8. Korean-language labelling applied
9. Market supply
10. Post-market obligations (ongoing)
    ├─ Adverse event reporting
    ├─ Post-market surveillance
    ├─ Re-examination (Grade III/IV — after 3–5 years)
    └─ Maintain KGMP, licences, UDI-K records

Typical timelines

Step	Duration
KGMP certification (domestic)	3–6 months
Foreign GMP recognition	3–9 months
품목허가 Grade III	3–6 months
품목허가 Grade IV	6–12 months
품목신고	1–4 weeks