Reimbursement and Market Access for Medical Devices in Korea
Obtaining a high device reimbursement price from Korea’s HIRA.
To learn more about Korea medical device reimbursement, please contact us.
Many medical devices bought in Korea are reimbursed by Korea’s National Health Insurance (NHI) system. Receiving government reimbursement is important for successful sales. However, some medical products do sell in Korea even without reimbursement.
Generally, only implantable or disposable medical devices are reimbursed separately; examples include pacemakers, spinal fixation products, drug-eluting stents, orthopedic trauma products, and sutures. All eligible devices must apply to Korea’s Health Insurance Review Agency (HIRA) for reimbursement within 30 days of product approval, and the reimbursement approval usually takes about 6 months. All non-reimbursed devices are traded at free market prices.
Under Korea’s regulations, medical devices are supposed to be grouped with predicate devices and given the lowest price among existing predicates. This is only avoidable if HIRA decides the product has significant advantages, in which case it may receive the highest price among existing predicates. If the product is completely new, HIRA may decide a new reimbursement price for it, but this will almost always be less than the reimbursement price in advanced Western countries. This situation generally does not favor novel medical products, and has recently been a source of contention in US-Korea trade talks.
To learn more about Korea medical device reimbursement, please contact us.
Related Resources
Visit our Resource Center to view free webcasts and charts or read publications, news, and research reports on the Asia medical markets.
Related News Briefs
Visit our Resource Center to view free webcasts and charts or read publications, news, and research reports on the Asia medical markets.