我国首部脑机接口医疗器械标准明年1月1日正式实施—— 脑机接口产业明确路线图 国家药监局日前批准发布《采用脑机接口技术的医疗器械术语》行业标准，明年1月1日正式实施，这是 我国第一部脑机接口医疗器械标准。此前，工信部等7部门印发《关于推动脑机接口产业创新发展的实 施意见》(以下简称《意见》)，提出到2030年，脑机接口产业创新能力显著提升，形成安全可靠的产业 体系，培育2至3家有全球影响力的领军企业和一批专精特新中小企业，构建具有国际竞争力的产业生 态，综合实力迈入世界前列。伴随各项政策的出台，脑机接口产业发展日趋标准化、体系化。 脑机接口通过在脑与机器之间建立信息通道，实现生物智能与机器智能的协同交互，是一项生命科学和 信息科学融合发展的前沿技术。近年来，随着创新成果持续涌现，脑机接口产业加速壮大。公开数据显 示，2024年中国脑机接口市场规模为32.0亿元，预计到2028年将达61.4亿元。 中国信息通信研究院总工程师敖立认为，《意见》的出台是中国在脑机接口领域从"跟跑"到"并跑"乃 至"领跑"的关键一步，为应对人口老龄化、提升国家安全能力、培育新质生产力提供战略支撑。 《意见》明确了加强基础软硬件攻关、 ...

Core Viewpoint - The approval of the first industry standard for brain-computer interface (BCI) medical devices in China marks a significant step towards the standardization and systematic development of the BCI industry, with a target market size of 6.14 billion yuan by 2028 [1][2]. Group 1: Policy and Standards - The National Medical Products Administration has approved the implementation of the "Terminology for Medical Devices Using Brain-Computer Interface Technology" standard, effective January 1, 2024 [1]. - The "Implementation Opinions" issued by seven departments, including the Ministry of Industry and Information Technology, aim to enhance innovation capabilities in the BCI industry and establish a reliable industrial system by 2030 [1][2]. - The establishment of a BCI technology standard system is emphasized to enhance the industry's support capabilities and promote international competitiveness [4]. Group 2: Market Potential and Applications - The BCI market in China is projected to reach 3.2 billion yuan in 2024 and grow to 6.14 billion yuan by 2028, indicating rapid industry growth [1]. - Key application areas for BCI technology include healthcare, industrial manufacturing, and consumer products, with significant potential for integration with AI, digital biology, and augmented reality [2]. - In healthcare, BCI can be utilized for diagnosing and rehabilitating neurological diseases such as epilepsy, Parkinson's, and Alzheimer's [2]. Group 3: Industry Development and Challenges - A number of innovative companies focusing on BCI technology have emerged, forming a relatively complete industrial chain, with some products already achieving medical device registration for rehabilitation [3]. - The global BCI industry faces challenges related to technology precision, industrial ecosystem strength, and ethical concerns regarding privacy and data management [3]. - Recommendations for further development include increased funding for key technology research, interdisciplinary talent cultivation, and exploration of new application scenarios [3]. Group 4: Collaborative Efforts - Strengthening collaboration among government, enterprises, and research institutions is crucial for advancing BCI technology and industry development [4]. - The need for coordinated efforts in technology research, industry growth, and safety governance is highlighted, along with the importance of local adaptation in promoting innovation [4].

国家药监局日前批准发布《采用脑机接口技术的医疗器械术语》行业标准，明年1月1日正式实施，这是 我国第一部脑机接口医疗器械标准。此前，工信部等7部门印发《关于推动脑机接口产业创新发展的实 施意见》（以下简称《意见》），提出到2030年，脑机接口产业创新能力显著提升，形成安全可靠的产 业体系，培育2至3家有全球影响力的领军企业和一批专精特新中小企业，构建具有国际竞争力的产业生 态，综合实力迈入世界前列。伴随各项政策的出台，脑机接口产业发展日趋标准化、体系化。 脑机接口通过在脑与机器之间建立信息通道，实现生物智能与机器智能的协同交互，是一项生命科学和 信息科学融合发展的前沿技术。近年来，随着创新成果持续涌现，脑机接口产业加速壮大。公开数据显 示，2024年中国脑机接口市场规模为32.0亿元，预计到2028年将达61.4亿元。 中国信息通信研究院总工程师敖立认为，《意见》的出台是中国在脑机接口领域从"跟跑"到"并跑"乃 至"领跑"的关键一步，为应对人口老龄化、提升国家安全能力、培育新质生产力提供战略支撑。 《意见》明确了加强基础软硬件攻关、打造高性能产品、推动技术成果应用、壮大创新主体、提升产业 支撑能力、保障措施等 ...