Policy

BrainCo's FocusXin Medical Edition combines a single-channel prefrontal EEG device registered as 浙械注准20232071898 with ADHD rehabilitation software registered as 浙械注准20252211934. The Class II system is intended for supplementary rehabilitation training in children aged 6 to 12 with ADHD. Its defined medical use should not be generalized into approval for an unspecified consumer BCI product.

Tongji Hospital in Wuhan implanted a 64-channel high-throughput flexible electrode array made by Wuhan Neuracom into a 31-year-old man paralysed by a spinal cord injury on 26 November 2025. The procedure was charged under the country's first BCI medical service price schedule, issued by Hubei's healthcare security bureau in March 2025, which sets implantation at 6,552 yuan. China's National Healthcare Security Administration calls it the first BCI operation in the country carried out under a state-set price. This patient's costs were covered by research funding.

The General Office of China's Jiangxi Provincial People's Government issued Several Measures for Accelerating the Development of Brain-Computer Interface Technology and Industry in Jiangxi on November 26, 2025, document number Gan Fu Ting Fa [2025] No. 29, setting out 11 measures across four areas. It was the first provincial document to follow the seven-ministry national guidance and is the only one that sets no quantitative industry targets at all. Its eleventh measure calls for implementing BCI research ethics guidelines and establishing mutual recognition of clinical research ethics review, a first among provincial documents. Other measures deploy a provincial major science and technology programme, back Ganjiang New Area in building a rehabilitation centre and a high-quality EEG dataset, and offer early regulatory engagement plus rewards for Class II and Class III innovative device approvals.

UNESCO's 43rd General Conference adopted the Recommendation on the Ethics of Neurotechnology, the first global framework, backed by 194 Member States.

ARC-EX is a non-invasive spinal cord stimulation device used to improve hand function in people with spinal cord injury; the CE mark allows commercial sale in the EU.

Thirteen departments in China's Shandong province, led by the Department of Science and Technology, jointly issued the Action Plan for Scientific and Technological Innovation in the Brain-Computer Interface Industry in Shandong (2025-2027), document number Lu Ke Zi [2025] No. 50, dated May 13, 2025 and released on May 16. By 2027 the province aims for roughly 20 breakthroughs in frontier and core technologies, about 30 innovative technology SMEs, two to three high-level talent teams, and one to two specialised incubators in areas rich in research and education resources, with applications reaching medicine, industry, elderly care, education and entertainment. By 2030 it expects an initial BCI industry ecosystem. The plan organises work into six campaigns and backs Jinan and Qingdao as innovation clusters. It is the first of Shandong's two provincial BCI documents and covers the industrial side.

Eight Sichuan provincial departments in southwestern China led by the Department of Economy and Information Technology issued the Action Plan for Breakthroughs in the Brain-Computer Interface and Human-Machine Interaction Industry in Sichuan (2025-2030) on May 12, 2025. The plan is unusual in making surgical volume a headline metric, targeting 3,000 invasive BCI procedures a year by 2030, along with services for more than 100,000 patients a year with neurodegenerative disease, psychiatric conditions and drug or digital addiction, and rehabilitation device use exceeding 20,000 sessions a year. By 2027 it aims to complete development and medical device registration of three invasive and five non-invasive products, carry out the province's first invasive BCI operation, serve more than 50,000 patients a year, and cultivate 10 chain-leading firms, 100 specialised SMEs and 200 innovative smaller enterprises. Chengdu, Mianyang, Deyang and Nanchong are named as host cities.

Shanghai's science commission issued a BCI industry action plan centering on medical-grade scenarios, with a clinical timeline for invasive and semi-invasive products.

Three Beijing agencies jointly issued a BCI action plan targeting 3-5 globally influential leaders and around 100 innovative SMEs by 2030.

California's SB 1223, enacted in 2024, amended the CCPA to classify neural data as sensitive personal information alongside genetic and biometric data.

Colorado's HB24-1058, signed in 2024, brought neural data under the state privacy act's sensitive-data protections, a first in the United States.

The US Bureau of Industry and Security announced a two-day hybrid BCI conference with industry and academic experts, following its 2021 export-control inquiry.

The FDA granted Breakthrough Device designation to Blackrock Neurotech's MoveAgain BCI System on November 16, 2021. The investigational system combines an implanted array, neural decoding and wireless output with the goal of allowing people with severe paralysis to control digital and assistive devices. The designation can expedite development and review but is not market approval.

The US Bureau of Industry and Security published a 2021 advance notice seeking comments on export controls for BCI as an emerging technology, focused on national security.

Chile's Ley 21.383, published in 2021, amended Article 19 of the Constitution to require special protection of brain activity, a world first.

The FDA issued final guidance in 2021 on implanted brain-computer interface (BCI) devices for patients with paralysis or amputation, covering nonclinical testing and clinical study design.

The OECD Council adopted the Recommendation on Responsible Innovation in Neurotechnology in December 2019, guiding governments with nine principles.