National Medical Products Administration: Strengthening registration guidance for products led by artificial intelligence and biodegradable materials.

According to the Zhongtong Financial APP, on July 3, the National Medical Products Administration issued a notice on optimizing the supervision of the entire life cycle to support the innovative development of high-end medical devices. It mentioned that innovative special review will continue to be implemented for high-end medical devices that are domestically pioneering, internationally leading, and have significant clinical application value, further optimizing the innovation review work, strengthening communication between applicants and review experts, and enhancing technical guidance for the research and registration of innovative medical devices. For changes in registration of high-end innovative medical devices, reviews will be conducted according to the innovative special review procedure. Support the rapid listing of high-end medical devices involved in the national high-quality development action plan and other industry policies. Strengthen the registration guidance for artificial intelligence and biomaterials "leading products", and cooperate with relevant departments to introduce support policies for medical devices based on brain-computer interface technology. For high-end medical devices approved with conditions according to the law, explore the specific requirements for conditional approval.