深圳市司法局、科技创新局发布了《深圳经济特区促进脑机接口产业创新发展若干规定（征求意见稿）》，通过一系列创新举措推动脑机接口科技与产业发展。1脑机接口已被列入国家"十五五"规划纲要重点培育的未来产业。1
该规定强化科技攻关支持、优化临床伦理审查机制、简化医疗器械审批流程。1深圳将编制脑机接口创新产品首购目录、优化政府采购等方式推广应用，打造脑机接口创新策源地和产业集聚地。1
在伦理审查和监管审批方面，市卫生健康部门将推动建立脑机接口临床研究伦理审查互认机制。1同时，深圳依托国家药监局医疗器械技术审评检查大湾区分中心，推行审评前置、检验联动、优先注册等举措。1
Shenzhen's Bureau of Justice and Bureau of Science and Technology Innovation have released a draft regulation titled "Shenzhen Special Economic Zone Regulations on Promoting Brain-Computer Interface Industry Innovation and Development" to advance the city's position in this emerging field.1 The proposed measures aim to establish Shenzhen as both an innovation source and industrial cluster center for brain-computer interface technology.1
The regulatory framework includes multiple strategic initiatives designed to accelerate development. These encompass strengthened support for technological breakthroughs, streamlined clinical ethics review mechanisms, and simplified medical device approval processes.1 The regulations propose establishing a brain-computer interface innovation product priority procurement directory and optimizing government purchasing practices to drive market adoption.1 Additionally, the health authorities are expected to develop an inter-institutional ethical review recognition mechanism for brain-computer interface clinical research.1
To facilitate product commercialization, the draft regulations leverage existing infrastructure by utilizing the National Medical Devices Technical Review and Inspection Center's Greater Bay Area branch under the State Administration of Medical Products Regulation, implementing pre-review advancement, inspection coordination, and priority registration procedures.1 Brain-computer interface technology has been designated as a key future industry within China's national development planning framework.1
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