国家药监局：完善高端医疗器械注册审查体系

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]