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Policy & Regulation

88 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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08-28 · 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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08-16 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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08-16 United States Policy & Regulation Regulatory Approval

FDA Clears FIND Neuro CN-Suite Localization Tool

The US Food and Drug Administration cleared CN-Suite, source localization software from FIND Surgical Sciences Inc., doing business as FIND Neuro, on August 16, 2026, finding it substantially equivalent under submission number K260563 via the Traditional 510(k) pathway. FDA lists the device as Source Localization Software for Electroencephalograph or Magnetoencephalograph, a Class II device under regulation number 882.1400, reviewed by the agency's neurology advisory committee. Such software works back from electrical or magnetic fields recorded at the scalp to the intracranial origin of the signal, supporting presurgical planning such as locating epileptic foci.
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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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07-02 · 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
06-30 United States Policy & Regulation Regulatory Approval

FDA Clears Universal Brain UB ERP System

The FDA cleared Universal Brain's UB ERP System on June 30, 2026, finding it substantially equivalent under submission number K253767 through the traditional 510(k) pathway. The agency classifies it as Non-Normalizing Quantitative Electroencephalograph Software, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Event-related potentials are obtained by averaging EEG time-locked to stimuli; components such as P300 serve both clinical assessment and the classic paradigms behind noninvasive BCI spellers.
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06-30 · Ceribell United States Policy & Regulation Regulatory Approval

FDA Clears Ceribell Monitor for Bedside EEG Recording

The FDA cleared the Ceribell Monitor on June 30, 2026, finding it substantially equivalent under submission number K261101 through the traditional 510(k) pathway. The agency classifies it as a Reduced-Montage Standard Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. It is one of several Ceribell clearances in the same period; the product line is built around rapid reduced-montage setup for bedside recording in emergency and critical care.
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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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06-24 · Ceribell United States Policy & Regulation Regulatory Approval

FDA Clears Ceribell Neurology Review Software

The FDA cleared the Ceribell Neurology Review Software on June 24, 2026, finding it substantially equivalent under submission number K260998 through the traditional 510(k) pathway. The agency classifies it as Automatic Event Detection Software for Full-Montage Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. The category covers software that automatically flags events within full-montage EEG recordings, surfacing candidate segments from long records for clinician review.
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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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06-13 · Neuroelectrics United States Policy & Regulation Regulatory Approval

FDA Clears Neuroelectrics Enobio Dx EEG Systems

The FDA cleared Neuroelectrics Barcelona's Enobio Dx line, in 8-, 20- and 32-channel models, on June 13, 2026, finding it substantially equivalent under submission number K261604 through the special 510(k) pathway. The agency classifies it as a Full-Montage Standard Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Neuroelectrics is known in neuromodulation and BCI research for noninvasive EEG acquisition and transcranial electrical stimulation hardware.
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06-12 United States Policy & Regulation Regulatory Approval

FDA Clears VoxNeuro Cognitive EEG Software

The FDA cleared VoxNeuro's Cognitive Function Neuroimaging (cfNI) Software, version 1.0.0, on June 12, 2026, finding it substantially equivalent under submission number K253015 through the traditional 510(k) pathway. The agency classifies it as Normalizing Quantitative Electroencephalograph Software, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Normalizing quantitative EEG software compares an individual's EEG metrics against a reference population database before reporting, supporting objective assessment of cognitive function.
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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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March 2026
03-13 · Zeto United States Policy & Regulation Regulatory Approval

FDA Clears Zeto New Wave EEG System

The FDA cleared Zeto's New Wave System on March 13, 2026, finding it substantially equivalent under submission number K260455 through the special 510(k) pathway. The agency classifies it as a Full-Montage Standard Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. That category covers standard electroencephalograph hardware acquiring a complete montage of scalp channels.
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