NMPA rolls out guiding principles for brain-computer interface devices

The National Medical Products Administration released two guiding principles for brain-computer interface medical devices on Tuesday, specifying product classification and generic naming rules for the emerging sector.

According to the documents, brain-computer interface medical devices are defined as medical equipment that measure neural signals generated by the central nervous system through invasive or noninvasive approaches and decode them in real time, enabling real-time, mutual interaction, or closed-loop feedback between patients and external devices.

Such devices aim to improve, restore, or replace certain functions of the central nervous system.

The documents also stressed that products that adopt brain-computer interface technology but are not regulated as medical devices shall have their intended use clearly stated as "not for medical purposes" and shall not claim to have medical effects such as improving, central nervous system functions.