National Medical Products Administration: Scientifically formulate review requirements for high-end medical devices and improve the registration review system for high-end medical devices

The National Medical Products Administration issued a notice to optimize the regulatory support for the entire lifecycle of high-end medical devices to promote innovative development. It mentioned the scientific formulation of review requirements for high-end medical devices and the improvement of the registration and review system for high-end medical devices. It aims to accelerate the formulation and revision of technical review guidelines for related products such as laparoscopic surgical systems, medical magnetic resonance imaging systems, oral bone filling materials for implants, and nickel-titanium alloy vascular interventional devices. It will research and develop relevant technical guidelines or review points in the fields of multi-disease and large model artificial intelligence; simplify the registration requirements for changes in artificial intelligence medical device products with optimized algorithm performance while maintaining core algorithms; explore and improve the requirements for performance evaluation of artificial intelligence medical devices using assessment databases; simplify review requirements for the same artificial intelligence software functions registered on different platforms if the equivalence of the platforms can be demonstrated. It will study the application of technologies such as artificial intelligence and biochips in the performance and safety evaluation of biomaterials medical devices. It will revise the technical review guidelines for the registration of service life of high-end active medical devices. It will explore the paths and requirements for using electronic instructions for high-end medical devices