Korea vs FDA · TGA · CE · PMDA · HSA
High-level comparison
| Feature | Korea (MFDS) | USA (FDA) | Australia (TGA) | EU (MDR/IVDR) | Japan (PMDA) | Singapore (HSA) |
|---|---|---|---|---|---|---|
| Classification grades | I, II, III, IV | Class I, II, III | Class I, IIa, IIb, III | Class I, IIa, IIb, III | Class I–IV | Class A–D |
| Pre-market review | Grade III/IV: MFDS review | 510(k), PMA | ARTG inclusion | CE marking (Notified Body) | Approval by PMDA | Product Registration |
| GMP | KGMP (MFDS-issued cert) | QSR (FDA inspection) | GMP (TGA or ISO 13485) | Annex I (ISO 13485) | JGMP (PMDA inspection) | ISO 13485 |
| Notified Body / CB | No (MFDS direct review) | No (FDA direct) | No (TGA direct) | YES — Notified Body | No (PMDA direct) | No (HSA direct) |
| UDI | UDI-K (KIMS) | GUDID (FDA UDI) | ARTG UDI | EUDAMED UDI | UDI-DI/PI | SDUDI |
| Re-examination | YES — unique to Korea | No equivalent | No equivalent | No equivalent | YES — similar system | No equivalent |
| Separate IVD Act | YES — separate IVD Act | No (single FDA act) | No | YES — separate IVDR | No | No |
Key unique features of Korean regulation
- Separate IVD Act — IVD devices regulated under a dedicated statute
- Re-examination (재심사) — unique mandatory post-market review for new approvals
- KGMP as prerequisite — GMP certification must be obtained before 품목허가
- AI/ML guidance — Korea was among the first to issue dedicated AI/ML medical device guidance