Policy & Regulation
China's NMPA has set a brain-computer interface classification framework: every implantable is Class III, and there is one narrow Class II lane
China's National Medical Products Administration issued Announcement No. 24 (2026) on 29 June 2026, releasing final Guiding Principles for the Classification and Definition of Brain-Computer Interface Medical Device Products plus a companion Generic Naming Guidelines. Every invasive BCI is Class III. Non-invasive BCIs are Class III by default. Non-invasive stroke-motor rehabilitation devices are Class II only if they do not incorporate artificial intelligence.