Marketing Authorization (품목허가) — Overview
품목허가 (Marketing Authorization) is required for Grade III and IV devices (and IVD Grades C and D). It is Korea's most rigorous pre-market pathway.
Prerequisites before applying
- Grade III or IV confirmed
- KGMP certification (domestic) or Foreign GMP Certificate (foreign) in place
- Business licence (제조업 허가 or 수입업 허가) active
- Technical documentation (STED) complete
Who holds the 품목허가?
- Korean manufacturer — holds the certificate directly
- For imported devices — the Korean importer (수입업자) holds it on behalf of the foreign manufacturer
Typical review times
| Grade | Typical timeline |
|---|---|
| Grade III | 3–6 months |
| Grade IV | 6–12 months |
| IVD Grade C | 3–6 months |
| IVD Grade D | 6–12 months |
Relevant legislation
- Medical Devices Act, Article 6 · IVD Act, Article 7