China has published the world's first medical device standard for brain-computer interfaces (BCIs) that use artificial intelligence to process brain signals, according to state broadcaster CCTV. The new standard, approved by the National Medical Products Administration (NMPA), will take effect on September 1, 2026.
The standard is the third BCI medical device standard issued by China, but the first globally to specifically address AI-based processing of electroencephalogram (EEG) data. It systematically defines technical requirements and testing methods across the entire workflow of BCI medical devices, including data collection, processing, labeling, storage, and access.
The move aims to solve common industry problems such as inconsistent data quality control and non-standard construction of datasets, which have hindered the development and approval of BCI devices. The NMPA said the standard provides a unified "quality yardstick" for EEG datasets, supporting innovation in this emerging field while ensuring patient safety.
What the standard means for the industry
BCI devices, often described as machines that can "read" brain signals, rely on AI algorithms trained on large volumes of EEG data to interpret a patient's intentions. In medical settings, these devices are used for applications such as assisting paralyzed patients to communicate or control prosthetics. The accuracy of these systems depends heavily on the quality and consistency of the data used to train them.
By setting clear requirements for data quality and processing, the new standard is expected to help manufacturers build more reliable and safe BCI products. It also reflects China's broader push to lead in AI and medical technology innovation, aligning with national goals to achieve full intelligence upgrades in key software by 2030.
The NMPA used a fast-track approval process to expedite the standard's release, citing the urgent needs of the industry. The regulator noted that the standard reaches an internationally advanced level, positioning China at the forefront of BCI standardization.
This development comes as global interest in BCI technology grows, with companies and research institutions exploring applications ranging from medical rehabilitation to consumer electronics. However, the field has also raised ethical and safety concerns, which the new standard aims to address by ensuring rigorous testing and data management.
According to IThome, the standard is part of a series of regulatory efforts in China to support major innovations in BCI medical devices. The publication of this standard is expected to accelerate the development and approval of AI-powered BCI products in China, potentially giving domestic companies a competitive edge in this cutting-edge field.
