China's Domestic Medical Device Innovation Accelerates, with High-End Products Rolling Out in 2026

　　【Pharmaceutical Network Industry DynamicsRecently, the "2025 Annual Medical Device Registration Work Report" released by the National Medical Products Administration (NMPA) showed that in 2025, the NMPA received 457 applications for special approval of innovative medical devices, of which 104 were approved to enter the special review process for innovative medical devices. Additionally, 38 priority applications were received, with 26 granted priority approval.
 

China's innovative medical device approval channel has significantly expanded. In 2025, the National Medical Products Administration approved 76 innovative medical devices, a year-on-year increase of 17%; and 25 medical devices through the priority approval process, reflecting a year-on-year increase of 212.5%. The approved products cover multiple cutting-edge fields including artificial intelligence, tumor radiotherapy, and biomedical materials.
 

According to reports, the special review and priority approval process for innovative medical devices is a core policy tool in China to encourage medical device innovation and accelerate the market entry of clinically urgently needed products. The innovation and priority approval data released by the National Medical Products Administration in 2025 clearly reflects that China's medical device innovation has shifted from a quantitative explosion to a qualitative leap, also demonstrating that the domestic evaluation system is becoming increasingly mature, precise, and efficient.
 

Notably, under the favorable policy environment, listed companies in China's medical device sector are becoming beneficiaries of the innovative approval channel, thanks to their investment in R&D, industrialization capabilities, and compliance advantages. Since 2026, multiple high-end products manufactured in China have been approved for marketing.
 

In late April, the National Medical Products Administration approved the innovative product registration application for Shenqi Medical's "Transcatheter Mitral Valve Clip System." According to reports, the product consists of a mitral valve clip and delivery system, as well as a guidance system. The valve leaflets can be independently captured, and the delivery system allows for multi-directional bending. The product is delivered percutaneously and is suitable for patients assessed by the cardiac team as having...Surgical OperationHigh-risk patients with degenerative mitral regurgitation (MR≥3+) and suitable mitral valve anatomy.
 

In early April, the i-NYS implantable ocular muscle neurostimulator, a treatment device for congenital nystagmus developed by Super Vision, received market approval from the National Medical Products Administration. The approved i-NYS can restore unsteady, involuntary eye movements to stability through personalized electrical stimulation interventions on the ocular muscles by setting specific current parameters. Clinical trials showed that, among 71 enrolled subjects, the foveal fixation time increased by 587% post-surgery, while the amplitude and frequency of nystagmus decreased by 84.1% and 79.4%, respectively, with no surgery-related adverse events reported.
 

In March, Neuracle's "Implantable Brain-Computer Interface Hand Movement Function Compensation System" officially received the Class III medical device registration certificate issued by the National Medical Products Administration. The product consists of an implantable brain-computer interface, an implantable electroencephalogram (EEG) electrode kit, an EEG signal transceiver, a pneumatic glove device, a disposable surgical tool kit, EEG decoding software, medical testing software, and clinical management software. It is suitable for patients with quadriplegia caused by cervical spinal cord injury, assisting in achieving hand grip function compensation through the pneumatic glove device.
 

　　……
 

Overall, under the influence of policy support, technological breakthroughs, optimized centralized procurement, and the integration of medical engineering, China's medical device industry is developing rapidly, with domestically produced innovative products being launched intensively. In the future, China’s medical device industry will move from being a "manufacturing giant" to an "innovation powerhouse." Companies that can grasp the four major trends of intelligence, globalization, grassroots focus, and platformization are expected to enter a golden period of development full of opportunities.
 

　　Disclaimer: In no event shall the information or opinions expressed in this article constitute investment advice to any person.