On November 21, Korea introduced the “Immediate Market Entry Medical Technology System,” a ground-breaking policy aimed at accelerating market entry for cutting-edge medical technologies. Before this system was initiated innovative devices could take up to 490 days to be approved. Under this new system, innovative devices such as medical robots, digital therapeutics, and AI-based diagnostic tools can enter the market within 80 to 140 days after receiving clinical evaluation. The clinical evaluation will include reviewing clinical data, relevant experience in advanced healthcare markets, international reports, doctor articles, etc. Confirmation of clinical evaluation will also trigger, at the same time, a review by the Health Insurance Review and Assessment Agency, better known as HIRA.
These technologically innovative products will be available to patients a lot sooner, and their safety and effectiveness will be closely observed over a three-year period. After this period ends, the MFDS will determine if the product has proven beneficial, and superior products may be evaluated for higher reimbursement. To determine whether the device is innovative and will be appropriate for this program, the MFDS will also offer specific consultation services.
To further this initiative, the Ministry of Health and Welfare has announced that it will establish a “Digital Health Promotion Agency” to lead the integration of digital health technologies into the country’s healthcare ecosystem. The agency will implement policies to encourage research and development in digital healthcare solutions and ensure the safety and efficacy of these technologies.
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.