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

3.5. Korean agent appointment — Foreign manufacturers must appoint a 한국 대리인 (Korean agent) to serve as local representative for all regulatory communications