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].

合作伙伴征集：2025全球手术机器人大会 报名：首届全球眼科大会 | 展位有限 1 .产品名称：外周动脉覆膜支架系统 申请人：江苏朴芃医疗科技有限公司 江苏朴芃医疗科技有限公司成立于2019年12月16日，是 臻亿医疗子公司， 其核心产品包括PAFLIVE ® 冠脉冲击波球囊导管系统及外周血管类医疗器械，其中， PAFLIVE ® 冠脉冲击波球囊导管系统利用冲击波技术对冠脉内钙化病变进行预处理，能够安全高效地破坏浅表与深层钙化，恢复血管弹性及血流，填补了国内相关 技术的空白。 2.产品名称：外周药物洗脱支架 申请人：上海畅德医疗科技有限公司 畅德医疗成立于2021年11月，位于上海。公司创始人及核心团队拥有丰富的介入耗材研发、临床注册和商业化经验，对聚焦的行业有深刻的理解。 畅德医疗秉承研发创新的核心理念，致力于高效打造一个能够满足血管疾病微创伤治疗的完整解决方案。公司在下肢动脉狭窄介入治疗、血栓管理、静脉疾病介入 治疗及慢性疾病管理等治疗领域发力，推出了外周血管约束型球囊扩张导管、间歇脉冲加压理疗仪、外周血栓抽吸系统等多款产品。 报名：首届全球心血管大会 | 奖项评选 报名：首届全球骨科大会 | 奖项评选 ...