NMPA Releases a New BCI Medical Device Standard

On September 14, 2026, the National Medical Products Administration issued Announcement No. 79 of 2026, releasing the medical device industry standard YY/T 2029—2026, Brain-Computer Interface Medical Devices — Quality Requirements and Evaluation Methods for EEG Datasets Used in Artificial Intelligence Algorithms. The standard has been reviewed and approved, and will take effect on September 1, 2027.

According to the attached Medical Device Industry Standard Information Sheet, the standard has serial number 1, standard number YY/T 2029—2026, and title Brain-Computer Interface Medical Devices — Quality Requirements and Evaluation Methods for EEG Datasets Used in Artificial Intelligence Algorithms. It is a newly formulated standard and replaces no previous standard. Its scope of application states that the document specifies quality requirements and evaluation methods for EEG datasets used in artificial intelligence algorithms in the field of BCI medical devices; it applies to datasets used in the R&D, production, and quality control of BCI medical devices that post-process EEG signals using artificial intelligence algorithms. The effective date is September 1, 2027.

The release of this standard provides unified quality requirements and evaluation methods for EEG datasets used by artificial intelligence algorithms in BCI medical devices. It helps standardize the construction and use of datasets in the R&D, production, and quality control of related products. For professionals in brain-computer interfaces, medical AI, neurotechnology, and data governance, this is a development worth following.