South Korea speeds up market entry for internationally evaluated medical devices

South Korea will reduce the time required for innovative medical devices that have undergone international clinical evaluations to enter the medical field, cutting the maximum waiting period from 490 days to as little as 80 days.

The Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) announced the implementation of the “Market Immediate Entry Medical Technology” system. Under this framework, new medical technology assessments will be waived for devices that have already undergone strengthened international-level clinical evaluations at the MFDS approval stage, allowing their immediate use in medical settings.

To support the new system, revisions have been made to the “Rules on New Medical Technology Evaluation” and the “Regulations on Medical Device Approval, Reporting, and Review”. Previously, new medical technology assessments—required to verify safety and effectiveness before clinical use—were considered complex and time-consuming, limiting the early introduction of advanced medical technologies.

Under the revised system, medical technologies using devices that have undergone international-level clinical evaluations are classified as “medical technologies that can enter the market immediately.” Applicants can confirm with the Health Insurance Review & Assessment Service whether a technology qualifies as existing technology. If not, the technology may be introduced directly into medical settings through a notice from the Minister of Health and Welfare, without a separate assessment.

The MOHW retains the discretion to conduct a new medical technology evaluation during the immediate entry period if needed, including decisions on health insurance coverage. Safety measures have also been introduced to prevent misuse of non-covered services and reduce the burden on patients.

At the 2025 MediExpo Korea, held at EXCO in Daegu on 20 June, exhibitors demonstrated medical devices eligible for the immediate entry system.

The MFDS has published a public notice procedure for devices eligible for immediate market entry and specified requirements for submitting clinical evaluation data. As of the announcement, 199 devices have been identified as eligible, including 113 digital medical devices, 83 in vitro diagnostic reagents, and three medical robots. Target items include standalone software medical devices using artificial intelligence, robotic surgical devices, in vitro diagnostic reagents, and powered exoskeletons.