Tag: NMPA

2 articles

Industry News

China performs first commercial Neuracle NEO implant

On Monday 13 July 2026, neurosurgeons at Huashan Hospital affiliated with Fudan University performed the first commercial implantation of Neuracle's NEO brain-computer interface in a male patient with tetraplegia from a decade-old cervical spinal cord injury. The device is coin-sized, epidural, battery-free, and drives a pneumatic glove for hand grasping. Neuracle NEO is the world's first commercial invasive brain-computer interface implant for motor restoration in paralysis, following NMPA Class III market approval on 13 March 2026.

Jul 16

Policy & Regulation

China's NMPA locks BCI device classification: every implant is Class III, 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.

Jul 4