Korea Launches Immediate Market Entry Program for Medical Technologies

Effective January 26, 2026, Korea’s Ministry of Health and Welfare (MOHW) and Ministry of Food and Drug Safety (MFDS) fully implemented the Immediate Market Entry Medical Technology program.
Under this program, 199 MFDS-designated product categories may enter clinical practice immediately after regulatory approval, based on the Clinical Evaluation Report (CER) submitted during the approval process.

Faster Access to Clinical Use
This policy fundamentally restructures procedures that previously took up to 490 days or more, including the New Health Technology Assessment (nHTA).