Korea runs a single-payer National Health Insurance (NHI) system that covers about 97% of the population, or roughly 52 million people. Ranked 10th globally and 3rd in Asia, the Korean medical device market was worth an estimated USD 7.5 billion in 2025. As a result, getting an NHI reimbursement listing is the main commercial goal for most manufacturers entering Korea.
Regulatory Institutions Responsible for Medical Device Reimbursement
Korea’s medical device reimbursement and market access system is primarily managed through the collaboration of three key regulatory institutions. The Ministry of Health and Welfare (MOHW) is the overarching government ministry that manages national health policies. The Health Insurance Review and Assessment Service (HIRA) decides whether a device is eligible for reimbursement by reviewing reimbursement applications and evaluating clinical and economic data. The National Evidence-based Healthcare Collaborating Agency (NECA) carries out health technology assessments (HTA), which systematically evaluate the clinical safety, efficacy, and economic value of new medical technologies and procedures
Device Approval and Reimbursement Timelines
Regulatory approval timelines depend on device class. Class I listings usually take 2–4 weeks, Class II certifications 3–6 months, Class III approvals 6–12 months, and Class IV approvals 8–15 months.
After approval, HIRA has 70 days to make a coverage determination. The Ministry of Health and Welfare (MOHW) then issues a final decision within 30 days of receiving HIRA’s report. For devices that require a new health technology assessment, the time from MFDS approval to reimbursement listing has historically ranged from 200 to 490 days.
Pricing Methodology
Korea uses external reference pricing based on the “A8” countries: the United States, Japan, the United Kingdom, France, Germany, Italy, Switzerland, and Canada. New devices are priced by default at the lowest price among existing predicate devices. As a result, a manufacturer must show a significant clinical advantage to justify a higher price. Novel devices without predicates usually receive prices above predicates but below those in Western markets.
Digital Medical Products and Reimbursement
MOHW and MFDS have both introduced measures to shorten the time it takes for new healthcare products to reach the Korean market. MOHW amended the Enforcement Rules on the Evaluation of New Medical Technologies to create the Immediate Market Technology Initiative. Under the initiative, an innovative device that already has some international approval and whose clinical data MFDS reviewed during registration can enter the Korean market without first going through an MOHW reimbursement review. To qualify, the device must be considered a “new item.” During this non-reimbursable period, MOHW can carry out a formal evaluation if problems arise. After the device has been on the market for three years, MOHW and HIRA review its cost-effectiveness and clinical results and then set a new reimbursement level.
For AI-based medical devices, approval does not guarantee hospital adoption. The MFDS has cleared a growing number of AI medical devices in recent years. However, many of these devices are not adopted by hospitals because they lack the clinical evidence and reimbursement coverage needed for routine use. To address this, MOHW announced a funding program on April 10, 2026, for the post-approval phase. The program covers clinical validation, real-world evidence generation, health economic studies, and reimbursement planning. Companies must form consortia with hospital partners to access the funding. These partnerships are expected to support multi-center clinical studies, real-world data collection, economic evidence, and commercialization. The program is part of the AX-Sprint initiative, a KRW 754 billion (over USD 510 million) effort to expand AI use across the Korean economy. A separate, related program will apply AI tools to chronic disease management
Post-listing Review
HIRA wants to review medical procedures on a regular basis after they are listed for reimbursement. Procedures account for over 70% of Korea’s health insurance spending, and no periodic review system covers them today. In January 2026, HIRA released a study that proposes reviewing each reimbursed procedure every five years. The reviews would look at whether a procedure is still clinically effective, cost-effective, and widely used.
Based on the review’s results, HIRA could stop reimbursing procedures that have had very few claims over three years. It could also lower coverage for procedures that have become less clinically effective, which means patients would pay more for them.
Many medical devices are used as part of specific procedures. Therefore, if HIRA reduces or ends coverage for a procedure, the devices used in it may see lower demand. Manufacturers should know which procedures their products depend on and how often those procedures are used.
Key Takeaways for Foreign Medical Device Manufacturers
Korea’s reimbursement system is moving in two directions at once: faster entry for designated technologies and closer review of existing listings. Manufacturers planning to enter Korea should prepare clinical and economic evidence for both HTA and HIRA review, check whether their product belongs to the immediate-entry categories, and plan for periodic reassessment after listing.
Written by: Ames Gross – President and Founder, Pacific Bridge Medical (PBM)
Mr. Gross founded PBM in 1988 and has helped hundreds of medical companies with regulatory and business development issues in Asia. He is recognized nationally and internationally as a leader in the Asian medical markets. Mr. Gross has a BA degree, Phi Beta Kappa, from the University of Pennsylvania and an MBA from Columbia University.