National Medical Products Administration: Strengthen registration guidance for artificial intelligence and biomaterial "flagship" products.

The National Medical Products Administration has issued a notice on optimizing the supervision and support of high-end medical device innovation throughout the entire lifecycle. It pointed out that innovative special reviews will continue to be carried out for domestically pioneering, internationally leading, and clinically valuable high-end medical devices that meet the requirements. The innovation review process will be further optimized, communication between applicants and review experts will be strengthened, and technical guidance for the research and registration of innovative medical devices will be enhanced. Changes in registration for high-end innovative medical devices will be reviewed according to the special innovation review procedure. Support will be provided for accelerating the market entry of high-end medical devices mentioned in national high-quality development action plans and other industry policies. Guidance for the registration of artificial intelligence and biomaterials products will be strengthened, and support policies for medical device products based on brain-machine interface technology will be coordinated with relevant departments. For high-end medical devices approved with conditions according to law, specific requirements for conditional approval will be explored.