On June 30, 2026, the National Medical Products Administration (NMPA) unveiled two pivotal documents: the Guiding Principles for the Classification and Definition of Brain-Computer Interface Medical Device Products and the Guiding Principles for the Naming of Generic Names of Brain-Computer Interface Medical Devices. These guidelines will take effect immediately upon issuance. According to the classification principles, brain-computer interface medical devices that utilize invasive or non-invasive techniques to measure signals from the central nervous system and decode them in real-time, thereby enabling bidirectional interaction or closed-loop feedback for medical objectives—such as enhancing, repairing, or substituting central nervous system functions—will be classified and regulated as medical devices. Conversely, devices intended for non-medical applications will not fall under this classification.

The naming principles, on the other hand, meticulously outline the structure for generic names of brain-computer interface medical devices, encompassing the selection of both core and characteristic terms. This ensures a standardized and systematic approach to naming, facilitating better understanding and categorization within the medical community.