Policy & Regulation

The Guangdong Provincial Department of Science and Technology in southern China is accepting 2027 BCI project applications from October 23 to 5 p.m. on November 23, 2026, with departmental recommendations due by 5 p.m. on December 3. Required self-raised funding is generally at least 70% of total investment for directions requiring an enterprise lead and 50% for other directions.

Neuracle Medical Technology (Shanghai) Co., Ltd. listed an Implanted EEG Electrode Kit, Model K1014-25, in the National Medical Products Administration's medical device unique identification database. The entry describes a kit containing a cortical electrode (1014-25) and supporting components, forming part of an implanted BCI hand motor function compensation system. The system also includes a BCI implant, an EEG transceiver, pneumatic glove equipment, and related software. The record identifies the kit and its relationship to the system; UDI listing itself is neither a new marketing authorization nor evidence of functional improvement in patients.

The Ministry of Commerce and eight other departments issued the Opinions on Accelerating the Promotion of Science and Technology for Commerce. The document calls for developing technology transfer and commercialization organizations focused on consumer goods to accelerate the transition of advances such as brain-computer interfaces and embodied intelligence into the market. It identifies BCI as a frontier technology for commercialization and institutional development as a concrete measure. This policy direction is not approval of a particular BCI product or evidence of clinical validation.

Neuracle Medical Technology (Shanghai) Co., Ltd. listed its Model 1014-35 cortical electrode in the National Medical Products Administration's medical device unique identification database. The entry identifies the electrode as a component of an implanted EEG electrode kit, which in turn forms part of an implanted BCI hand motor function compensation system. The system also includes a BCI implant, an EEG transceiver, pneumatic glove equipment, and related software. The entry clarifies these component relationships; UDI listing itself is neither a new marketing authorization nor evidence of clinical effectiveness.

Neuracle Medical Technology (Shanghai) Co., Ltd. listed its Model 1014-25 cortical electrode in the National Medical Products Administration's medical device unique identification database. The entry identifies the electrode as part of an implantable EEG electrode kit, which is a component of an implantable BCI hand motor function compensation system. The full system also includes a BCI implant, an EEG transceiver, pneumatic glove equipment, and related software. The record identifies the electrode and its relationship to the kit and system; UDI listing itself is neither a new marketing authorization nor clinical evidence of improved hand function.

Neuracle Medical Technology (Shanghai) Co., Ltd. listed its K1014-35 Implantable EEG Electrode Kit in the National Medical Products Administration's medical device unique identification database. The entry describes a kit containing a cortical electrode (1014-35) and supporting components, forming part of an implantable BCI hand motor function compensation system. The complete system also includes a BCI implant, an EEG transceiver, pneumatic glove equipment, and related software. The record identifies the kit and its relationship to the system; UDI listing itself is neither a new marketing authorization nor evidence of safety or functional improvement in patients.

Neuracle Medical Technology (Shanghai) Co., Ltd. listed its Model 1014-15 cortical electrode in the National Medical Products Administration's medical device unique identification database. The entry identifies the electrode as a component of an implantable EEG electrode kit, which forms part of an implantable BCI hand motor function compensation system. The system also includes a BCI implant, an EEG transceiver, pneumatic glove equipment, and related software. The record specifies the electrode's model, identifier, and relationship to the system; UDI listing itself is neither a new marketing authorization nor clinical evidence of improved hand function.

The Shanghai Municipal Science and Technology Commission in eastern China is coordinating applications for the first batch of 2027 projects under the national brain science and brain-inspired research initiative. Online submission runs from November 4 to December 4, 2026, through the national science and technology management platform, with attachments uploaded as scans.

Neuracle Medical Technology (Shanghai) Co., Ltd. listed its K1014-15 Implantable EEG Electrode Kit in the National Medical Products Administration's medical device unique identification database. The entry describes a kit containing a cortical electrode (1014-15) and supporting components, forming part of an implantable BCI hand motor function compensation system. The complete system also includes a BCI implant, an EEG transceiver, pneumatic glove equipment, and related software. The record identifies the kit and its relationship to the system; UDI listing itself is neither a new marketing authorization nor evidence of safety or improved hand function in patients.

China’s NMPA UDI database lists Neuracle’s NEO-M and NEO-M Pro hand motor function compensation system models under registration certificate 国械注准20263120537, and K1014-25 and K1014-35 implantable EEG electrode kits under 国械注准20263120536. The descriptions identify the system’s implantable components, EEG transceiver, pneumatic glove and software.

The US Food and Drug Administration has cleared EEG Analysis Software from Ceribell, a US medical device company, through the 510(k) pathway after finding it substantially equivalent to a device already on the market. The software performs quantitative analysis of EEG signals and is regulated as a Class II device under the Neurology review panel. A 510(k) clearance only requires showing equivalence to an existing product, a lower bar than the premarket approval required for high-risk devices. The FDA record does not describe the software's indications or specific analysis functions.

Jiangsu's industry department and eight other agencies issued a BCI action plan in March 2026 that invites companies in hazardous chemicals, nuclear power, mining and electric power to pilot the technology first. Nearly all its numeric targets, including at least 20 registered medical products, fall in 2030, and a widely cited RMB 6,600 implant price appears only in a 2025 draft, not in the province's final pricing notice.

As of September 14, 2026, 11 of China's 31 provincial-level regions had issued dedicated BCI policy documents, but Hainan, Qinghai and Xinjiang had published BCI medical service prices without any industry plan. Hubei, Hunan, Chongqing and Henan have BCI initiatives but no dedicated documents, and 16 other regions show neither.

Beijing issued China's first provincial-level brain-computer interface (BCI) action plan on January 7, 2025, setting every 2027 and 2030 target in terms of companies and platforms rather than output or revenue. The plan calls for three to five unicorns or would-be unicorns by 2027 and around 100 innovative small and medium-sized firms by 2030. On the payment side, Beijing prices invasive BCI implantation at RMB 7,980 per procedure and covers all three BCI service fees under Category A of basic medical insurance, limited to four hospitals.

Shanghai's science and technology commission issued a BCI action plan on January 10, 2025, pledging to help blind patients partially regain sight by 2030 and to have more than five invasive or semi-invasive products complete medical device type testing by 2027. The city's healthcare security bureau created three BCI service fee items in August 2025 but left prices to hospitals and explicitly excluded them from basic medical insurance payment.

Sichuan's industry department and seven other agencies issued a BCI and human-machine interaction plan on May 12, 2025, targeting 3,000 invasive BCI operations a year by 2030 and the registration of three invasive and five non-invasive products by 2027. The province prices BCI services in five tiers by hospital grade, with implantation ranging from RMB 6,583 to RMB 4,389, all paid out of pocket.

Shandong's health commission and 15 other agencies issued a BCI clinical translation plan on July 7, 2026, following a 2025 industry plan led by the provincial science department. The 14-measure plan sets up a clinical research alliance and a provincial clinical database, cuts review time for Class II devices to 90 working days, and targets more than 30 multicenter validation projects and a RMB 2 billion industry by 2028.

Jiangxi issued BCI support measures on November 26, 2025 that set no numeric targets but called for mutual recognition of clinical research ethics reviews, and its health commission followed on May 26, 2026 with guidance requiring participating sites to finish recognition reviews within 10 working days. Invasive projects for neurological or psychiatric treatment also need provincial expert review within 20 working days.

Fujian's science department and five other agencies issued a 2026-2030 BCI action plan on August 9, 2026, making the province the 11th in China with a dedicated BCI policy. It plans a cross-strait joint laboratory with Taiwanese research institutions and companies by 2027 and targets 30 innovative companies and a RMB 3 billion industry by 2030.

Tianjin's municipal government issued a 2026-2030 BCI action plan on May 26, 2026 that limits every numeric product target to non-invasive devices, aiming for more than ten in large-scale clinical use by 2030, while invasive products get a single unquantified approval goal. The plan also targets an industry fund cluster of more than RMB 10 billion by 2030.

Hubei became the first Chinese province to publish BCI medical service prices on March 31, 2025, capping invasive implantation at RMB 6,552, and Wuhan hosted China's first BCI operation charged at the government guidance price in November 2025. The province has no dedicated BCI policy document, and its prices carry no insurance payment category.

Zhejiang became the first Chinese province to reimburse a BCI service when it covered non-invasive fitting fees under Category B insurance from September 1, 2025, limited to smart bionic prosthesis fittings. Its 18 industry-academia-research measures, dated July 16, 2026, cut review of qualifying Class II BCI devices to 40 working days and offer research hospitals up to RMB 8 million per project.

Anhui issued a 2026-2030 BCI action plan on June 15, 2026 that sets its near-term milestones in 2028 rather than 2027 and frames every target as a minimum, including at least three approved invasive BCI clinical trials. Research leadership goes to the University of Science and Technology of China, with Hefei as the hub, Bengbu handling key components and Wuhu clinical translation.

Guangdong's provincial Party science and technology committee office issued a 2026-2030 BCI plan on June 5, 2026 that calls for 200 BCI hospital wards serving more than 500,000 patients cumulatively by 2030. The plan assigns invasive devices and signal decoding to Shenzhen and non-invasive systems to Guangzhou, and follows provincial BCI prices set nine months earlier, with implantation capped at RMB 6,600.

Neuracle Medical Technology (Shanghai) Co., Ltd. has registered a cortical electrode, model 1014-35, in the medical device unique identification (UDI) database of China's National Medical Products Administration (NMPA), under registration certificate Guoxiezhuzhun 20263120536. Neuracle's product line spans EEG acquisition equipment and implantable electrodes. The electrode belongs to an implantable EEG electrode kit (cortical electrode, blank electrode, electrode dilator, tunneler, torque wrench, lead fixation clip, fixation screws and electrode protective sleeve) that holds its own registration certificate and is also a component of an implantable BCI hand motor function compensation system. That system comprises a BCI implant, the electrode kit, an EEG signal transceiver, a pneumatic glove, a single-use surgical toolkit, and three software packages for EEG decoding, medical testing and clinical management.

Pascall Systems, Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pascall Sensor Unit (PSU1) on August 19, 2026, with the agency finding the device substantially equivalent. The device is a Class II medical device under regulation number 882.1400, classification name Non-Normalizing Quantitative Electroencephalograph Software.

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.