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]

Core Viewpoint - The National Medical Products Administration (NMPA) of China has released the "Priority Approval Catalog for High-end Medical Devices (2025 Edition)", which includes eight advanced medical devices for expedited approval, aiming to accelerate the market entry of innovative high-end medical equipment [1]. Group 1: Priority Approval Catalog - The catalog includes advanced medical devices such as the boron neutron capture therapy system, ultra-high field magnetic resonance imaging equipment, medical electron accelerators, and implantable brain-machine interface devices [1][2]. - The NMPA will implement priority approval for the medical devices listed in the catalog according to Article 73, Item 3 of the "Regulations on the Registration and Filing of Medical Devices" [1][5]. Group 2: Device Specifications - The boron neutron capture therapy system is designed to treat malignant tumors that are recurrent or for which there are no other conventional treatment options, utilizing a reaction between neutrons and boron to produce secondary particles that kill cancer cells [2]. - The ultra-high field magnetic resonance imaging equipment has a magnetic field strength greater than 5 Tesla [2]. - The medical electron accelerator integrates magnetic resonance imaging guidance and is used for various therapeutic applications [2]. - The implantable brain-machine interface device captures neural signals from the central nervous system through implanted electrodes, enabling interaction with external control devices for compensating motor and sensory dysfunctions [2]. - The endoscopic surgical control system employs robotic technology for operating surgical instruments through natural orifices [2]. - The transcatheter tricuspid valve repair system is suitable for high-risk patients with severe tricuspid regurgitation who are deemed unsuitable for surgical intervention [2]. - The minimally invasive glaucoma surgery (MIGS) implant establishes a drainage pathway for aqueous humor in the eye [2].