The Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) announced the implementation of the ‘Immediate Market Entry Medical Technology’ system, allowing innovative medical devices that have passed international-level clinical evaluations to enter the market without separate new technology assessments from January 26, 2026. Previously, new medical technologies faced lengthy and complex evaluation processes before market entry, but this reform enables faster adoption of advanced technologies. The system is based on amendments to the Regulations on New Medical Technology Evaluation and Medical Device Approval, Notification, and Review. Patient safety and non-reimbursed usage monitoring will also be strengthened.
Previously, market entry for medical technologies could take up to 490 days, but the new system reduces this to as little as 80 days. The MFDS designated 199 items, including digital medical devices, in vitro diagnostic devices, and medical robots, as eligible for immediate market entry. This includes 113 digital medical devices and 83 in vitro diagnostic reagents, as well as automated surgical robots. Clinical evaluation data will be collected from clinical trials, real-world experience, and literature to ensure safety and efficacy. The MOHW and MFDS are collaborating closely to implement the system.
Kwak Soon-heon, Director of Health Policy at the MOHW, emphasized that streamlining market entry procedures will revitalize the medical device industry and support the early adoption of outstanding technologies. He also stated that the government will monitor non-reimbursed usage to reduce patient burden and remove unsafe technologies from the market. Nam-hee Lee, Director of Medical Device Safety at the MFDS, expressed expectations that the new system will ease market entry for companies using innovative technologies like AI, expanding treatment opportunities for patients. Both agencies will require robust clinical evaluation data to ensure patient safety.
With this reform, innovative medical technologies can enter the market more quickly, strengthening the industry’s competitiveness and improving patient access to advanced treatments. Enhanced monitoring of non-reimbursed usage and safety evaluations will further protect patients. Ongoing cooperation among relevant agencies is planned to ensure the system’s successful implementation. Detailed information on the amendments is available on the National Law Information Center, MOHW, and MFDS websites.
This regulatory reform marks a significant turning point for Korea’s medical device industry, enhancing global competitiveness and enabling rapid adoption of innovative technologies. The accelerated introduction of AI and digital healthcare solutions will drive personalized treatment and healthcare innovation. At the same time, strengthened clinical evaluations and non-reimbursed usage management will ensure patient safety and cost control, delivering broad benefits to both the industry and society.