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Policy

77 entries
August 2026
08-31 · Ministry of Commerce +1 more China Policy & Regulation Industrial Planning

Seven Chinese Ministries Put Brain-Machine Tech in Elder Care Product Plan

Seven Chinese ministries, led by the Ministry of Commerce and including the National Development and Reform Commission and the Ministry of Industry and Information Technology, jointly issued implementing opinions on expanding and upgrading consumer goods (《关于推动商品消费扩容升级的实施意见》). In a section on products for older adults, the document calls for stronger R&D on key technologies and core components and for wider use of brain-machine integration and artificial intelligence in age-friendly products and rehabilitation aids. Brain-computer interfaces have until now figured mainly in China's science and industrial planning documents; framing them as consumption policy aimed at two named product categories is new, and the text was published in the State Council's policy document database, the central government's official repository for such documents.
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08-31 China Policy & Regulation Industrial Planning

Guangdong Drafts 2027 Rules for a Standalone BCI Research Track

The Guangdong Provincial Department of Science and Technology in southern China (广东省科学技术厅) has opened public consultation on the 2027 application guidelines for a brain-computer interface track within the province's key-fields R&D program, one of the main channels through which Guangdong allocates research money. A dedicated track gives the field its own entry point rather than making it compete inside a broader category. Because such guidelines normally set research directions, funding levels and eligibility, comments at this stage bear directly on where next year's money goes; the notice went up on the department's own website and does not carry the text of the guidelines.
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08-28 · Xiangya Hospital, Central South University +3 more China Policy & Regulation Industrial Planning

BCI Plans Across 10 Chinese Provinces All Target 2030, Only Zhejiang and Beijing Reimburse

Ten provincial-level regions have issued 12 brain-computer interface (BCI) policy documents as of August 2026, with hard numeric targets almost exclusively set for 2030, which makes the next four years critical for clearing regulatory and payment hurdles. The payment gate is the tightest constraint, as only Zhejiang and Beijing have moved BCI items into basic medical insurance reimbursement, each with conditions attached. This means most provinces still have to solve reimbursement before the 2030 targets can be met.
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08-18 China Industry News Industrial Planning

Fujian Targets a 3 Billion Yuan BCI Industry by 2030

Six Fujian government departments jointly issued a provincial BCI action plan for 2026–2030. It calls for key technical breakthroughs, more than five innovative small and medium-sized companies, one cross-strait joint laboratory and two provincial innovation platforms by 2027; by 2030, Fujian aims to have 30 companies, a complete industry chain and an industry worth more than 3 billion yuan.
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08-18 China Industry News Industrial Planning

Chinese Insurers Begin Covering BCI Procedures and Surgical Risk

Chinese insurers have begun introducing BCI-related coverage. Shanghai's 2026 Hu-huibao plan added up to 150,000 yuan for out-of-pocket materials used in inpatient BCI surgery, PICC Property and Casualty underwrote an invasive-BCI surgical accident policy for the Second Affiliated Hospital of Zhejiang University School of Medicine, and China Pacific Property Insurance covered patients receiving Neuracle's NEO implant at Huashan Hospital.
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08-16 China Policy & Regulation Standards

BCI Pricing in Eleven Chinese Jurisdictions: Implantation RMB 4,389-7,980, Insurance Coverage in Two

Eleven Chinese provincial-level jurisdictions had published prices for brain-computer interface medical services. The invasive implantation fee runs from RMB 4,389 at the lowest hospital tier in Sichuan to RMB 7,980 in Beijing (approx. $650 to $1,180 at RMB 6.74 to the dollar, the mid-August 2026 rate), and the non-invasive fitting fee from RMB 643 to 990. Sichuan, Hainan, Qinghai and Xinjiang tier prices by hospital grade, Shanghai leaves the amount to each hospital, and Jiangsu's three figures appear only in a July 2025 draft. Beijing lists all three fees as Class A at four named hospitals; Zhejiang covers the fitting fee as Class B, limited to prosthetic fitting. Sichuan, Jiangxi, Hainan, Qinghai and Xinjiang assign Class C, Shanghai excludes the fees, and Hubei and Guangdong have prices without a coverage decision.
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08-12 · General Office of the Zhejiang Provincial People's Government China Policy & Regulation Industrial Planning

Zhejiang Cuts BCI Device Review to 40 Days

The General Office of China's Zhejiang Provincial People's Government issued Several Measures for Promoting Industry-University-Research Coordination in Brain-Computer Interfaces, document number Zhe Zheng Ban Fa [2026] No. 33, dated July 16, 2026 and released on August 12, comprising 18 measures in five areas. Class II BCI devices of clear clinical value may enter a special review procedure with the timeline cut to within 40 working days, while medical consumables are listed through a green channel within 10 working days. Funding comes in four tiers: up to 10 million yuan for a provincial major science and technology project, up to 8 million yuan for research hospitals deeply involved in preclinical work and product launch, up to 3 million yuan for applied basic research, and 1 million, 500,000 and 100,000 yuan for leading international, national and local standards. Beds used solely for clinical research are exempt from efficiency and DRG performance assessment.
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08-01 China Policy & Regulation Standards

China's First National Standards for Brain-Computer Interfaces Take Effect

Two national standards for brain-computer interfaces took effect in China on 1 August 2026, the first foundational standards the field has had there. GB/T 47023 defines a reference architecture for BCI systems; GB/T 47127 sets a common format for multimodal data, down to directory structure and file naming. Both carry the GB/T prefix, marking them as recommended rather than mandatory, so they bind no one by law and work only as far as industry and procurement choose to adopt them.
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July 2026
07-27 · NeuroXess China Policy & Regulation Regulatory Approval

NeuroXess 'Sanquan' BCI Enters CMDE Innovative Medical Device Review Program

NeuroXess announced that its self-developed implantable brain-computer interface system for hand motor function compensation — the 'fully implanted, fully wireless, fully functional' ('Sanquan') system — has passed public notice and formally entered the innovative medical device special review program of the National Medical Products Administration's Center for Medical Device Evaluation (CMDE), commonly known as the green channel. The company describes it as the first subdural implantable flexible BCI product in China to enter the program. The system began a GCP registration clinical trial at Huashan Hospital, Fudan University on July 7, 2026, run as a multicentre study across 15 Class III hospitals nationwide, with trial data intended to support a Class III medical device registration application with the NMPA. The system remains in the review and clinical-trial stage and has not yet been approved for market; the registration timeline reflects company statements and remains subject to regulatory notice.
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07-13 · Ministry of Civil Affairs China Policy & Regulation Industrial Planning

China Integrates BCI in Rehabilitation Device Innovation

Chinese authorities recently issued a three-year action plan for the rehabilitation assistive-device industry that integrates brain-computer interface (BCI), artificial intelligence and flexible electronics with rehabilitation device development, and pursues medical-engineering collaboration to drive technical breakthroughs in materials and components.
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07-08 · Health Commission of Shandong Province China Policy & Regulation Industrial Planning

Shandong Bids to Be China BCI Testing Hub

Sixteen departments in China's Shandong province, led by the Health Commission, issued the Work Plan for Accelerating Clinical Translation and Application Innovation of Brain-Computer Interfaces, document number Lu Wei Yi Zi [2026] No. 13, dated July 7, 2026 and released on July 8. It is the only provincial BCI document led by a health authority and Shandong's second after the science department's industry plan. The plan advances a positioning it summarises as validated in Shandong, applied globally, working through an alliance, scenarios, policy and industry follow-through. Targets rise in four steps: an operating clinical research alliance in 2026; about 20 core technology breakthroughs and 30 technology SMEs by 2027; at least 30 alliance members, more than 20 foreign and domestic teams setting up validation bases, more than 30 multicentre projects and a 2 billion yuan industry by 2028; and a national validation cluster by 2030.
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07-06 · Shenzhen Hanix United China Media Coverage Progress & Expansion

Chinese Rehabilitation Association Sets July Workshop on Closed-Loop EEG-TMS

The Chinese Association of Rehabilitation Medicine will hold a workshop on EEG-driven closed-loop TMS in Guangzhou, southern China, on July 17, 2026, staged under its Naoke China (脑客中国) series and run by its committee on brain function monitoring and modulation in rehabilitation. The technique reads EEG in real time and triggers a TMS pulse when a target brain state appears, a 'brain-state-dependent stimulation' approach that pairs the spatial precision of TMS with the temporal resolution of EEG, and the program is built around moving BCI work out of the laboratory into neurorehabilitation and the precision diagnosis of brain disorders. Shenzhen Yingchi Technology, a subsidiary of Hanix United, is among the supporting organizations, and registration closes on July 17.
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07-02 · Ministry of Industry and Information Technology China Policy & Regulation Industrial Planning

China's MIIT and Six Ministries Issue BCI Industry Development Guidelines

Seven Chinese ministries led by MIIT issued guidelines targeting breakthroughs in core BCI technologies by 2027 — including electrodes, chips, and integrated devices at internationally competitive levels — with accelerated deployment in manufacturing, healthcare, and consumer markets. By 2030, the plan calls for cultivating 2–3 globally influential BCI companies and building an internationally competitive industry ecosystem.
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June 2026
06-29 · Saluda Medical AustraliaUnited States Policy & Regulation Regulatory Approval

FDA Approves Label Changes for Saluda Medical's Spinal Cord Stimulators

The FDA approved a premarket approval (PMA) supplement, S039, from Saluda Medical Pty, Ltd. on June 29, 2026, covering the CAP24 Paddle Lead, Passing Elevator, Evoke CLS (REF 3042), Clarity Programming Application (CPA) and RECAP Viewer. The supplement is a labeling change touching indications, instructions for use, shelf life and trade name rather than an original approval of a new device; the products carry the generic name 'stimulator, spinal-cord, totally implanted for pain relief.' Saluda Medical is an Australian company whose Evoke system is one of the few closed-loop spinal cord stimulators on the market.
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06-17 · Neuracle China Policy & Regulation Regulatory Approval

Neuracle Registers UDI for NEO-M Hand Motor Function Compensation System

Neuracle registered the NEO-M Implantable Brain-Computer Interface Hand Motor Function Compensation System in the NMPA Medical Device Unique Identification database. Its registration certificate number is 国械注准20263120537. According to the company's description, the system includes a BCI implant, an implantable EEG electrode kit, a disposable surgical tool kit, an EEG signal transceiver, a pneumatic glove device, and EEG decoding, medical testing, and clinical management software. All three software products have release version 1.0. The entry identifies the product and its components; UDI registration itself does not validate clinical efficacy or safety.
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06-17 · Neuracle China Policy & Regulation Regulatory Approval

Neuracle Registers UDI for K1014-35 Implantable EEG Electrode Kit

Neuracle Medical Technology (Shanghai) Co., Ltd. registered the K1014-35 Implantable EEG Electrode Kit in the NMPA Medical Device Unique Identification database. Its registration certificate number is 国械注准20263120536. The company's description lists a cortical electrode, a blank electrode, and associated tools and fixation components. It describes the kit as both a product with its own registration certificate and a component of an implantable brain-computer interface hand motor function compensation system. The notes also list an EEG transceiver, a pneumatic glove device, and software within that system. The kit's UDI entry alone does not confirm the complete system's registration status or clinical performance.
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06-17 · Neuracle China Policy & Regulation Regulatory Approval

Neuracle Registers UDI for K1014-25 Implantable EEG Electrode Kit

Neuracle Medical Technology (Shanghai) Co., Ltd. registered the K1014-25 Implantable EEG Electrode Kit in the NMPA Medical Device Unique Identification database. Its registration certificate number is 国械注准20263120536. According to the company's registered description, the kit includes a cortical electrode, a blank electrode, and associated tools and fixation components. It is both a product with its own registration certificate and a component of an implantable brain-computer interface hand motor function compensation system. The entry also lists the system's EEG transceiver, pneumatic glove device, and software. It identifies the kit and its relationship to the system; UDI registration itself does not validate clinical efficacy or safety.
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06-17 · Neuracle China Policy & Regulation Regulatory Approval

Neuracle Registers UDI for NEO-M Pro Hand Motor Function Compensation System

Neuracle Medical Technology (Shanghai) Co., Ltd. registered the Implantable Brain-Computer Interface Hand Motor Function Compensation System in the NMPA Medical Device Unique Identification database. Its model is NEO-M Pro, and its registration certificate number is 国械注准20263120537. The description lists a BCI implant, an implantable EEG electrode kit, a disposable surgical tool kit, an EEG signal transceiver, a pneumatic glove device, and three software products, each with release version 1.0. The entry provides product identification and composition information; UDI registration itself should not be interpreted as validation of clinical efficacy or safety.
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06-17 · Neuracle China Policy & Regulation Regulatory Approval

Neuracle Registers UDI for Implantable EEG Electrode Kit

Neuracle Medical Technology (Shanghai) Co., Ltd. registered an Implantable EEG Electrode Kit in the NMPA Medical Device Unique Identification database. The model is K1014-15, and the registration certificate number is 国械注准20263120536. The listed kit includes a cortical electrode, a blank electrode, and surgical and fixation components. It is both a product with its own registration certificate and a component of an implantable brain-computer interface hand motor function compensation system. The system also includes an implant, an EEG transceiver, a pneumatic glove device, and software. This entry identifies the product and its composition; it does not establish the complete system's registration status or clinical performance.
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06-15 · General Office of the Anhui Provincial People's Government China Policy & Regulation Industrial Planning

Anhui Splits BCI Work Across Three Cities

The General Office of China's Anhui Provincial People's Government issued the Action Plan for Accelerating Brain-Computer Interface Technology and Industry Development in Anhui (2026-2030) on June 15, 2026, document number Wan Zheng Ban Mi [2026] No. 24. Its spatial layout assigns Hefei the role of innovation origination and talent attraction, Bengbu the fabrication and validation of key components on the strength of its smart sensor industry plus a new Longhu Laboratory, and Wuhu clinical translation through a national regional medical centre and a brain science institute at Wannan Medical College. The first main task backs the University of Science and Technology of China in leading a research institute with Chinese Academy of Sciences partners. Targets fall in 2028 rather than 2027, covering at least ten application scenarios, three approved invasive clinical trials, five systems and three backbone firms.
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May 2026
05-28 · General Office of the Tianjin Municipal People's Government China Policy & Regulation Industrial Planning

Tianjin Plans 10bn Yuan BCI Fund Cluster

The General Office of China's Tianjin Municipal People's Government issued the Action Plan for Promoting Innovative Development of Brain-Computer Interfaces in Tianjin (2026-2030), document number Jin Zheng Ban Fa [2026] No. 8, dated May 26, 2026 and released on May 28. All product targets sit on the non-invasive track, while invasive systems are covered only by milestones for entering registration trials and winning market approval. By 2027 Tianjin wants two to three national-level innovation platforms, more than five non-invasive products in clinical use, more than ten new products across elderly care, education, entertainment, smart living and advanced manufacturing, 50 innovative firms, one to two national standards, and three to five industry funds. By 2030 it targets more than ten non-invasive products in large-scale clinical use, market approval for invasive products, and a fund cluster exceeding 10 billion yuan.
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05-26 · Jiangxi Provincial Health Commission China Policy & Regulation Ethics & Governance

Jiangxi Sets 10-Day Clock on BCI Ethics Review

The Jiangxi Provincial Health Commission in eastern China issued Guidelines for Ethics Review of Brain-Computer Interface Clinical Research Projects on May 26, 2026, document number Gan Wei Ke Jiao Fa [2026] No. 8, providing implementing detail for the mutual recognition mechanism proposed in the province's November 2025 BCI measures. For multicentre projects the lead institution's ethics committee conducts the first full review; participating institutions should finish within 10 working days of receiving complete materials and examine only local research conditions, staff qualifications and the informed-consent process; and the lead institution must file with the provincial medical ethics expert committee within 10 working days. Invasive projects treating neurological or psychiatric disease need provincial committee review within 20 working days, with an opinion issued within a further seven.
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April 2026
04-07 · Huazhong University of Science and Technology +1 more China Industry News Industrial Planning

China Hubei Approves a Provincial BCI Innovation Centre Led by a Hospital

On 31 March 2026 Hubei's provincial science and technology department approved the formation of a provincial brain-computer interface technology innovation centre, led by Tongji Hospital in Wuhan together with 12 organisations including Huazhong University of Science and Technology and Hubei Optics Valley Laboratory. Chinese reports describe it as the country's first provincial BCI platform positioned as comprehensive and full-chain. Its stated priorities are neural signal decoding, domestic sourcing of core components, and refining both non-invasive and implanted approaches. It is headed by Tang Zhouping, the hospital's party secretary.
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March 2026
03-10 · Department of Industry and Information Technology of Jiangsu Province China Policy & Regulation Industrial Planning

Jiangsu Opens BCI to Nuclear and Mining Work

Nine Jiangsu provincial departments in eastern China led by the Department of Industry and Information Technology issued the Action Plan for Innovative Development of the Brain-Computer Interface Industry in Jiangsu in March 2026, implementing national guidance from seven ministries. Its most distinctive provision covers industrial deployment, directing firms in hazardous materials, nuclear power, mining and electricity to pilot BCI systems in safety management and deep-sea and deep-pit operations, sectors no other provincial document names. Headline goals are at least two provincial clusters by 2027 and two to three leading enterprises by 2030. Its quantitative targets sit at the end of 14 tasks and all fall in 2030, including at least 15 programme projects, 15 key technology tasks, about 10 innovation platforms, 30 certified flagship products, 20 registered medical devices and a dataset of at least 20,000 samples.
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