国家药监局：科学制定高端医疗器械审评要求 完善高端医疗器械注册审查体系

Core Viewpoint - The National Medical Products Administration (NMPA) is optimizing the regulatory framework for high-end medical devices to support innovation and improve the registration review system [1] Group 1: Regulatory Enhancements - The NMPA is formulating scientific review requirements for high-end medical devices and enhancing the registration review system [1] - There is a focus on expediting the revision of technical review guidelines for various medical devices, including laparoscopic surgical systems and medical MRI systems [1] - The agency aims to develop technical guidelines for multi-disease and large model artificial intelligence applications [1] Group 2: Artificial Intelligence and Performance Evaluation - The NMPA plans to simplify registration requirements for AI medical devices that optimize core algorithms without changing their fundamental functions [1] - There is an exploration of using evaluation databases for assessing the performance of AI medical devices [1] - The agency will simplify review requirements for AI software functions that demonstrate equivalence across different platforms [1] Group 3: Safety and Performance Standards - Research will be conducted on the application of technologies like AI and biochips in evaluating the performance and safety of biomaterials in medical devices [1] - The NMPA is revising technical review guidelines for the usage period of high-end active medical devices [1] - There is an exploration of pathways and requirements for using electronic instructions for high-end medical devices [1]