A draft bill has been introduced in Korea to increase the scope of devices that can receive a designation as “innovative medical devices“. Innovative devices are those that would enhance the convenience and quality of diagnosis and treatment. At present, only devices with enhanced safety and efficacy can be designated as innovative, and usability is not taken into account. If the bill is passed, significant incentives such as reduced government fees, tax breaks, and participation in national R&D projects will be available to more device companies.
Korea’s Ministry of Food and Drug Safety (MFDS) has requested 812.2 billion won ($582 million) in its 2026 budget, an increase of 8.3% from 2025. The proposed funding increase will be used for the government’s commitment to strengthening pharmaceutical safety, increasing oversight of AI-based products, and modernizing food and drug regulations. Some highlights include 15 billion won (around 11 million USD) designated to expedite the commercialization of AI-based medical and food products. Also, there will be a more than twentyfold increase in regulatory science funding to 11.4 billion won (around 8 million USD). The MFDS will be expanding support for orphan drugs, cosmetics safety, and control of narcotics, while also investing more in expediting drug approvals.
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.