The Korean Ministry of Health and Welfare (MOHW) and the Ministry of Food and Drug Safety (MFDS) are seeking new ways to counteract long registration and market access timelines for healthcare products. Both agencies have been vigorously implementing new ways to get innovative drugs and devices into Korea sooner. Accordingly, the MOHW is issuing a change amendment to the Enforcement Rules on the Evaluation of New Medical Technologies, which is called the Immediate Market Technology Initiative. While maintaining patient safety, this regulation will facilitate the entry of new, innovative medical devices into Korea a lot sooner.
New innovative devices that have already received some international approval and have had their clinical data reviewed during the MFDS registration review process can now enter the Korean market without going through an MOHW reimbursement review. To be eligible to be considered an innovative medical device, it will need to be considered a “new item.” During this non-reimbursable period, the MOHW can perform a formal evaluation of the innovative device if any problematic issues arise. Once the innovative device is on the market for 3 years, the MOHW and the Health Insurance Review and Assessment Service (HIRA) will review the cost-effectiveness and clinical success of the device before settling on a new, higher reimbursement.
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.