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 through pre-submission consultation, or preliminary classification provided by applicant in technical dossier (MFDS confirmation recommended before formal application) 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)