Korea’s Ministry of Health and Welfare (MOHW) announced a new funding program on April 10, 2026. The initiative is designed to speed up the commercial rollout of AI-based medical devices. It focuses on the post-approval phase, where many products encounter challenges, as some devices are not adopted by hospitals even after receiving regulatory approval. Support for AI medical devices will cover clinical validation, real-world evidence generation, health economic studies, and reimbursement planning. The program is part of the broader AX-Sprint initiative, a 754 billion won (over 510 million USD) effort to scale AI applications across the Korean economy.
The government has been steadily increasing its investment in AI and digital health. Regulators, particularly the Ministry of Food and Drug Safety (MFDS), have already cleared a growing number of AI medical devices in recent years. However, approval alone has not guaranteed adoption in hospitals. Many devices struggle to move forward because they lack the clinical evidence and reimbursement frameworks needed for routine use.
Under this program, companies will need to form consortia with hospital partners in order to access the funding. These partnerships are expected to support multi-center clinical studies and real-world data collection. They will also help generate economic evidence and support commercialization efforts. A separate but related program will apply AI tools to chronic disease management across care delivery.
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.