Following successful product registration and Korea Good Manufacturing Practice (KGMP) Certification, foreign medical device manufacturers who intend to sell their product to public hospitals will need to apply for reimbursement through the Health Insurance Review and Assessment Service (HIRA), through their Korea License Holder.
HIRA is an agency created and managed by the Ministry of Health and Welfare (MoHW). HIRA completes technical reviews for reimbursement applications, approves products for reimbursement and sets reimbursement prices for medical devices, with final approval from the MoHW. Device manufacturers can submit their application to HIRA once their registration has been submitted to the Ministry of Food and Drug Safety (MFDS) for regulatory approval. However, HIRA applications must be submitted no later than 30 days after MFDS device approval.
This is a mandatory listing - i.e., if a device is intended to be sold for use in a hospital or clinic, it must be on the reimbursements listing; otherwise, hospitals and clinics cannot order the device to be used in procedures. Only devices that are sold over the counter are exempt from HIRA listing.
Implement your reimbursement strategy in South Korea
From our office in Seoul, Emergo can fully support your reimbursement registration effort once you have obtained approval for your medical device. Our Korea Reimbursement Registration service includes identifying your device’s applicable product category in the HIRA database, determining which level of reimbursement you qualify for, and submitting required cost effectiveness data to compare your device with others in its product category.
Please contact us for more information about our Reimbursement Services in South Korea.