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]

Group 1 - The medical device sector experienced a strong start in 2026, with multiple stocks hitting the daily limit up, including Mindray Medical, United Imaging, and South Micro Medical, among others [1] - The Medical Device Index ETF (159898) saw a significant increase of over 5%, with a net subscription of 27 million units and a net inflow of over 15 million yuan [1][2] - Recent government initiatives, such as the National Medical Products Administration's (NMPA) establishment of a priority approval list for high-end medical devices, aim to accelerate the market entry of innovative products [3] Group 2 - The medical device sector has gained attention in specific areas like brain-computer interfaces, indicating potential for continued performance [3] - The NMPA's new regulations on export sales certificates for medical devices will facilitate better pricing strategies for companies in the global market [3] - Century Securities suggests that domestic medical device manufacturers have gained significant market share post-consolidated procurement, benefiting from scale effects and export policies [4] Group 3 - The Medical Device Index ETF (159898) tracks the CSI All-Index Medical Devices, with major holdings in leading companies like Mindray Medical and United Imaging, reflecting a strong representation of the A-share medical device sector [4]

Core Viewpoint - The medical device sector is experiencing significant growth, with notable stock increases for companies like Lepu Medical, Mindray, and United Imaging, driven by favorable regulatory developments and market sentiment [1][2]. Group 1: Stock Performance - Lepu Medical's stock surged by 20%, while Mindray and United Imaging saw increases of over 4% [1]. - Medical device-related ETFs rose by more than 5%, indicating strong investor interest in the sector [1]. Group 2: Regulatory Developments - The National Medical Products Administration has developed a "Priority Approval List for High-end Medical Devices (2025 Edition)," which includes advanced technologies such as medical electronic accelerators and implantable brain-machine interface devices [2]. - The inclusion of these high-end products in the priority approval category highlights the government's support for technological advancements in the medical device industry [3]. Group 3: Market Potential - The brain-machine interface sector is characterized by diverse application scenarios and rich research and development pathways, suggesting a broad potential market space [3]. - With supportive policies for product registration and medical insurance project approvals, the commercialization process for these technologies is expected to accelerate [3].

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].

Core Viewpoint - The National Medical Products Administration (NMPA) has developed the "Priority Approval Directory for High-end Medical Devices (2025 Edition)," which includes medical electronic accelerators, implantable brain-machine interface medical devices, and endoscopic surgical control systems [1] Summary by Relevant Categories Regulatory Changes - The NMPA will implement priority approval for medical device registration applications listed in the directory according to Article 73, Item 3 of the "Regulations on the Registration and Filing of Medical Devices" [1] Approval Process - The Medical Device Technical Review Center of the NMPA will review the registration application materials for the products in the directory. If the review proposes priority approval, the results will be publicly announced, and if there are no objections, the application will enter the priority approval process [1] - If the review does not propose priority approval, the reasons will be communicated to the applicant, and the application will be processed according to standard procedures [1]

Core Viewpoint - The National Medical Products Administration (NMPA) has developed the "Priority Approval Directory for High-end Medical Devices (2025 Edition)" which includes advanced medical devices such as medical electronic accelerators, implantable brain-machine interface devices, and endoscopic surgical control systems [1] Group 1 - The NMPA will implement priority approval for medical device registration applications listed in the directory according to Article 73, Item 3 of the "Regulations on the Registration and Filing of Medical Devices" [1] - The Medical Device Technical Review Center of the NMPA will review the registration application materials for the products in the directory [1] - If the review proposes priority approval, the results will be publicly announced, and if there are no objections, the application will enter the priority approval process [1]