China's National Medical Products Administration(NMPA)has issued the country's third medical device standard for brain-computer interfaces(BCI).

It is the world's first product standard for BCI medical devices that adopts artificial intelligence to process electroencephalogram (EEG) data. The new standard will take effect on September 1, 2027.

The new standard regulates the technical requirements and testing methods across the entire process of data collection, processing, annotation, storage and access for BCI medical devices.

It applies to datasets used in the R&D, manufacturing and quality control of BCI medical devices in which AI algorithms are employed for the post-processing of EEG signals.

According to NMPA, a BCI medical device acts like an intelligent machine that can "read" brain signals. It needs to learn massive EEG data and train AI algorithms to accurately interpret patients' intentions. This bears heavily on treatment outcomes and patient safety risks.

Li Shu, drafter of the standard and deputy director of the medical device institute of the National Institutes for Food and Drug Control, explained that prior to the release of the new standard, research institutions and enterprises used varying methods for EEG data collection. Some adopted 64 channels while others used 128 channels; sampling frequencies varied from 2 Hz to 1000 Hz, and annotation practices differed. Data collected in such ways resembled documents written in different "dialects," making cross-party comparison and reuse difficult.

The new standard provides a unified quality benchmark for EEG datasets used in R&D and manufacturing of BCI medical devices, reaching an internationally leading level.

In March, the BCI was incorporated into the 2026 Government Work Report and was listed as a key future industry in the 15th Five-Year Plan (2026-2030).

In August, the Ministry of Industry and Information Technology released the draft guidelines for the development of the national BCI industrial standard system. It targets the formulation and revision of over 40 BCI standards by 2028, as well as participation in developing more than 10 international standards.