Group 1 - The National Medical Products Administration (NMPA) has announced measures to optimize the lifecycle regulation to support the innovation and development of high-end medical devices [1] - The announcement includes strengthening the standard system for high-end medical devices, accelerating the release of standards for medical exoskeleton robots and radioactive nuclide imaging equipment [1] - The NMPA aims to advance the standardization of medical robots, AI medical devices, and high-end medical imaging equipment, and establish standardization technical organizations for these fields [1] Group 2 - The NMPA is formulating review requirements for high-end medical devices and improving the registration review system [2] - The agency plans to expedite the revision of technical review guidelines for various medical devices, including laparoscopic surgical systems and medical magnetic resonance imaging systems [2] - The NMPA is exploring the use of electronic instructions for high-end medical devices and simplifying review requirements for AI medical devices based on platform equivalence [2]

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]