According to a research report released by CITIC Securities, the newly issued "National Brain-Computer Interface Industry Standards System Construction Guide (2026 Edition)" establishes a comprehensive standardization roadmap covering the entire industry chain. This development is expected to enhance the standardization of industry development, allowing companies with core technologies, engineering expertise, clinical validation capabilities, and compliance strengths to build competitive advantages. The establishment of these standards is likely to accelerate technology validation and product finalization, promoting specialized division of labor across the industry chain. The report recommends focusing on three key investment directions: 1) Hardware: autonomous controllability of core components such as electrodes and chips; 2) Algorithms: companies with rich data accumulation and leading algorithm development capabilities; 3) Applications: breakthroughs in clinical translation within the medical field, alongside clear application scenarios and commercialization channel advantages in non-medical sectors.

The top-level design of the brain-computer interface standards system has been further refined, with the pace of industry standardization expected to accelerate. On August 25, the Ministry of Industry and Information Technology's Department of Science and Technology publicly solicited opinions on the "National Brain-Computer Interface Industry Standards System Construction Guide (2026 Edition)" (draft for comments). The Guide proposes formulating or revising over 40 brain-computer interface standards by 2028, leading or participating in the development of more than 10 international standards, and promoting standard publicity and implementation across over 100 enterprises. By 2030, cumulative standards development is expected to exceed 80, with the brain-computer interface standards system largely taking shape. The report suggests that clear targets for standard development, implementation, and internationalization will provide clearer regulations for technological innovation, product development, and application scenarios, driving high-quality industry growth.

The seven major standard segments cover the entire industry chain, potentially establishing a unified industry "yardstick." The Guide constructs a seven-part standards system covering fundamental commonalities, hardware, software and algorithms, data and communications, products and systems, industry applications, and security/governance. This encompasses terminology classification, reference architecture, typical paradigms, testing and evaluation, as well as product development and application governance. Brain-computer interfaces integrate multiple fields including neuroscience, materials, chips, algorithms, and clinical medicine, with different technical routes requiring unified standards for interfaces, data, and performance evaluation. The report believes these standards will improve comparability of research results and software-hardware compatibility, reduce upstream-downstream adaptation costs, and promote specialized division of labor and collaborative innovation across the industry chain.

Core hardware standards have been further clarified, with electrodes, chips, module components, and key instruments expected to benefit significantly. The Guide outlines standards for electrode materials, biocompatibility, chemical stability, MRI condition safety, corrosion resistance, and mechanical and conductive properties. Chip standards cover sampling signal-to-noise ratio, stimulation precision, biological interference resistance, temperature control, packaging, and bus interfaces, while module components address sealing, power supply energy consumption, reliability, and safety. Additionally, the standards system incorporates key instruments such as multimodal detection, electrical stimulation regulation, and electrode implantation. As electrode, chip, module component, and hardware interface standards gradually become defined, performance evaluation and upstream-downstream adaptation of related products will become more standardized. Hardware companies with core technologies, engineering capabilities, and reliability validation strengths are expected to be key beneficiaries.

Software, algorithm, and data standards are expected to promote interconnection, enhancing platform development and data utilization value. The Guide covers brain-computer interface data formats, long-term storage, real-time communication, multimodal fusion, data visualization, as well as encoding/decoding model architecture, training processes, validation methods, and performance evaluation. It also proposes standardizing algorithm-model interfaces, interoperability, and compatibility. Unified data formats and software interfaces will likely facilitate coordination between different devices, algorithms, and execution units, improving system interoperability and compatibility while providing clearer technical specifications for EEG data development and utilization, real-time encoding/decoding algorithms, general software platforms, and data security.

Medical device and medical application standards have been further defined, potentially accelerating standardized product development and clinical translation. The Guide lists brain-computer interface medical device products and systems separately, covering invasive and non-invasive complete units, electrodes, signal acquisition and processing controllers, execution devices, and specialized implantable equipment. Typical applications include diagnosis, treatment, compensation, functional reconstruction, rehabilitation training, and closed-loop neural stimulation for central nervous system dysfunction. Specific applications involve motor, sensory, speech, and visual function reconstruction, as well as conditions such as epilepsy, Parkinson's disease, stroke, spinal cord injury, and depression. Meanwhile, the Guide clarifies that brain-computer interface products meeting medical device definitions must strictly comply with existing medical device regulations and standards. These standards will provide clearer technical benchmarks for product design, performance validation, and clinical evaluation, facilitating coordination among medical institutions, enterprises, and testing organizations while supporting standardized development and clinical translation of rehabilitation equipment, neuromodulation devices, and both invasive and non-invasive complete units.

Testing and evaluation standards have been further specified, with diverse application scenarios expected to accelerate standardized development. The Guide proposes standards for signal simulation, physiological environment simulation, structural characterization and measurement, animal experimentation evaluation, electromagnetic compatibility, and environmental adaptability. It also plans application standards for medical, industrial, transportation, health, education, gaming and entertainment, and virtual reality sectors. The implementation of these standards is expected to drive development of testing equipment, third-party inspection and testing services, and standardized public service platforms. On the application side, areas such as industrial safety monitoring, driver status monitoring, sleep health, elderly care and disability assistance, exoskeleton enhancement, and brain-controlled interaction are expected to gain clearer product development and scenario implementation foundations.

Risk factors include: slower-than-expected standard development and promotion progress; slower-than-expected core technology research and engineering progress; slower-than-expected clinical trials and registration progress for medical devices; underperformance in product safety, efficacy, and commercialization; and changes in data security and ethical governance requirements.