《优先审批高端医疗器械目录（2025版）》发布

Core Points - The National Medical Products Administration (NMPA) has released the "Priority Approval Directory for High-end Medical Devices (2025 Edition)" which includes eight types of products such as boron neutron capture therapy systems and high-field magnetic resonance imaging equipment [1][2] - The directory aims to implement the State Council's directive on deepening the reform of drug and medical device regulation to promote high-quality development in the pharmaceutical industry [1] - The NMPA will prioritize the approval process for the listed medical devices according to specific regulations, ensuring a streamlined review process for these innovative products [1] Summary by Categories Product Categories - The directory includes eight high-end medical devices: 1. Boron neutron capture therapy systems 2. High-field magnetic resonance imaging equipment 3. Medical electron accelerators 4. Implantable brain-machine interface medical devices 5. Endoscopic surgical control systems 6. Transcatheter tricuspid valve replacement or repair systems 7. Implantable glaucoma drainage devices for minimally invasive glaucoma surgery (MIGS) 8. Membrane oxygenators for ECMO [1] Regulatory Framework - The NMPA has established the directory in accordance with the "Regulations on the Registration and Filing of Medical Devices" and the announcement on optimizing lifecycle supervision to support the innovative development of high-end medical devices [1] - The approval process will follow Article 73, Item 3 of the Medical Device Registration and Filing Management Measures, allowing for expedited review of applications for the listed devices [1] Implementation and Future Adjustments - The directory will take effect immediately upon publication, with the NMPA indicating that it may adjust the list as necessary in the future [2]