China's brain-computer interface (BCI) sector has received another boost. On November 11, Shanghai-based Step Medical Technology's self-developed "Implantable Wireless Brain-Computer Interface System" was officially included in the National Medical Products Administration's (NMPA) special review program for innovative medical devices. This marks the first invasive BCI product in China to qualify for this fast-track approval, signaling a critical transition from clinical validation to market entry. The system aims to treat severe neurological disorders, and its inclusion in the "green channel" will expedite commercialization, accelerating China's BCI industrialization.
Policy support for BCI has intensified this year. On September 15, the NMPA released the YY/T 1987—2025 standard, "Medical Device Terminology for Brain-Computer Interface Technology," the first technical standard for China's BCI medical device industry. This provides a unified framework for R&D, production, and regulation, marking a milestone in BCI's transition from innovation to application.
2025, the final year of China's 14th Five-Year Plan, is expected to bring a wave of policy-driven growth for BCI. In July, multiple ministries, including the Ministry of Industry and Information Technology and the National Health Commission, jointly issued the "Implementation Opinions on Promoting the Innovative Development of the Brain-Computer Interface Industry," outlining key milestones. By 2027, breakthroughs in core BCI technologies are expected, alongside the establishment of advanced technical, industrial, and standardization systems. By 2030, the sector aims to achieve significant innovation, a secure industrial ecosystem, and 2-3 globally influential enterprises, positioning China as a global leader in BCI competitiveness.
Clinical progress is also accelerating. The Chinese Academy of Sciences' Center for Excellence in Brain Science and Intelligence Technology, in collaboration with Huashan Hospital and industry partners, has launched a prospective clinical trial for invasive BCI, making China the second country after the U.S. to reach this stage. Major hospitals, including Tongji Hospital and Beijing Tiantan Hospital, have established specialized BCI clinics and research units, shifting focus from academic research to clinical application.
Dongwu Securities highlights China's policy momentum and rapid clinical-commercial progress as key drivers for the BCI industry. Globally, over 3 billion people suffer from neurological disorders such as stroke, Alzheimer's, epilepsy, and autism. Huafu Securities notes that advancements in neuroscience, AI, and cognitive science continue to expand BCI's potential.
China's BCI industry benefits from a complete supply chain, spanning upstream (materials, chips, electrodes), midstream (signal processing), and downstream (healthcare, consumer, industrial) segments. According to Precedence Research, the global BCI market is projected to grow from $262 million in 2024 to $1.24 billion by 2034.
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