National Medical Products Administration: Strengthening registration guidance for artificial intelligence and bio-materials products.

date
04/07/2025
The State Drug Administration issued a notice on optimizing the supervision of the entire life cycle to support the innovative development of high-end medical devices. It supports the accelerated listing of high-end medical devices related to the national-level high-quality development action plan and other industrial policies. It strengthens the registration guidance for artificial intelligence and biomaterial "flagship" products, and cooperates with relevant departments to introduce policies to support medical devices based on brain-machine interface technology. For high-end medical devices that are conditionally approved according to law, specific requirements for conditional approval are being explored.