SaMD used for CDSS Approved for National Health Insurance/Reimbursement in Korea
작성자 관리자날짜 2023-01-03 09:35:56조회수 181
The Health Insurance Review and Assessment Board ("HIRA") of Korea announced late last year in October 2022 that it would revise the health reimbursement criteria to qualify for national healthcare insurance reimbursement for "innovative medical technology". Currently, in order for innovative and novel medical devices to enter the Korean market, there are four major steps that must be cleared as follows: 1) Product license from the Ministry of Food and Drug Safety ("MFDS"), 2) HIRA Assessment on whether the approved technology is novel or existing, 3) New medical technology assessment from NECA, and 4) Reimbursement qualification as a new medical act by HIRA. The amendments mentioned above pertain to changes in 2).The amended guideline provides that if a product that is titled an "innovative medical device" is approved for a product license by the MFDS, then HIRA would automatically assume that such technology is new and non-existing and will streamline NECA's assessment process (#3) and HIRA's reimbursement qualification assessment (#4) so that the timing needed to register and properly enter the Korean market can be minimized. Furthermore, the new guidelines now permit concurrent assessment and approvals of a product assessment and registration for steps 1-4 stated above, which will further minimize the waiting period for businesses to get their products ready for the Korean market going forward.With these amendments to the guidelines, we expect SaMD products that act as a CDSS to receive a major boost in obtaining national healthcare insurance qualification and the eventual approval to enter the Korean market.
Please feel free to reach out to us at pro@mdrex.co.kr if you have any questions regarding SaMD or any medical device regulatory related questions for the Korean market.