[2026-01-27]Korea Launches Fast-Track System for Innovative Medical Devices, Reducing Entry to 80 Days
The Ministry of Health and Welfare and the MFDS will implement the ‘Immediate Market Entry Medical Technology’ system from June 26, exempting innovative devices with international clinical evaluation from new technology assessment.
This reform shortens the entry period for medical devices from up to 490 days to as little as 80 days, covering 199 items including 113 digital devices.
Safety measures and controls against non-reimbursed overuse are included, aiming to boost industry innovation and accelerate adoption of advanced technologies.