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 device classification confirmed by MFDS (or applicant's technical dossier) Active KGMP certification (for domestic manufacturers) or Foreign GMP Certificate issued by MFDS-recognised authority (for foreign manufacturers) Active business licence: 제조업 허가 (manufacturer licence) or 수입업 허가 (importer licence) Complete technical file (STED) including full performance test reports from MFDS-recognised testing laboratory
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
Application procedure
Submit via MFDS eSubmission portal with: • Completed 품목허가 application form • Full technical documentation (STED) • Performance test reports from MFDS-recognised testing laboratory • Korean-language labelling (label and Instructions for Use) • Valid KGMP/Foreign GMP certificate • Business licence copy • Clinical evaluation report (for higher-risk Grade IV devices)
MFDS conducts scientific review of all submitted documentation before issuing 품목허가증 (Marketing Authorization Certificate).