On June 26, the Ministry of Health and Welfare and the Ministry of Food and Drug Safety (MFDS) announced the implementation of the ‘Immediate Market Entry Medical Technology’ system. This new policy exempts innovative medical devices that have undergone international-level clinical evaluations from the New Health Technology Assessment, allowing them to be used in medical settings immediately. Previously, the process for introducing new medical devices could take up to 490 days, but this period will now be shortened to as little as 80 days. The change aims to address criticism that lengthy and complex evaluation procedures have hindered the early adoption of advanced medical technologies.
To implement this system, the government revised the ‘Regulations on New Health Technology Assessment’ and the ‘Regulations on Medical Device Approval, Notification, and Review.’ The MFDS announced 199 eligible medical device items for immediate market entry, including 113 digital medical devices, 83 in vitro diagnostic reagents, and 3 medical robots. Eligible devices feature advanced technologies such as artificial intelligence (AI), standalone software, in vitro diagnostic reagents, surgical robots, and powered exoskeletons. Applicants must confirm with the Health Insurance Review and Assessment Service that the technology is new; if so, it can be used immediately without further assessment.
To prevent misuse of non-reimbursed services and reduce patient burden, safety measures have been established. The Minister of Health and Welfare can still conduct a New Health Technology Assessment during the immediate entry period if necessary and decide on insurance coverage. The MFDS has also set requirements for submitting clinical evaluation data to verify the diversity and safety of clinical applications and established a formal announcement process for eligible items. Kwon Soon-heon, Director of Health Policy at the Ministry of Health and Welfare, emphasized the goal of revitalizing the medical device industry and supporting the early adoption of outstanding medical technologies.
This system is expected to reduce the burden on innovative medical device companies and enhance the competitiveness of Korea’s medical device industry. Patient safety will remain a top priority, with ongoing monitoring of non-reimbursed usage and strengthened cooperation among relevant agencies to ensure stable implementation. Detailed information on the revised laws and notifications is available on the National Law Information Center and the websites of the Ministry of Health and Welfare and the MFDS. The initiative marks a significant turning point for medical technology innovation and improved patient access in Korea.
The introduction of this fast-track system represents a major advancement for Korea’s medical device sector, aligning regulatory processes with global standards and accelerating innovation. By eliminating redundant assessments for devices with robust clinical validation, the policy lowers barriers for companies and speeds up patient access to cutting-edge treatments. This approach not only fosters industrial growth but also ensures that safety and efficacy remain uncompromised, setting a benchmark for regulatory reform in healthcare.