South Korea’s Ministry of Health and Welfare said it will fund the commercialisation of AI-based medical devices by backing post-approval market entry activities, including clinical validation, real-world evidence generation and reimbursement pathway development. The programme, targeting 2026–2027 support, requires companies to form consortia with hospital-level providers to qualify. Backing will cover multi-centre clinical studies, real-world data collection, economic evaluation and marketing to help products meet regulatory and payer expectations.
Officials say the move aims to lower commercial barriers and accelerate clinical adoption of medical AI by coupling evidence generation with reimbursement strategy. Requiring hospital consortia is intended to strengthen clinical validation and real-world uptake, while economic evaluation support targets payer acceptance. Observers note success will depend on consortium quality and sustained funding, but the initiative positions South Korea as a proactive backer of medical AI commercialization.
