National Medical Products Administration (NMPA)
China's regulator for drugs and medical devices. It approved Neuracle's NEO-ONE SCI implant in March 2026 and has since set the classification and data rules that any brain-computer interface company selling in China must plan against.
Overview
The National Medical Products Administration (NMPA) is China’s regulator for drugs and medical devices. For brain-computer interface companies it decides market access, device class and the evidence a product needs before Chinese hospitals can buy it.
What it has done on BCI
On 13 March 2026 the NMPA approved Neuracle’s NEO-ONE SCI, a Class III epidural implant for hand motor function in people with tetraplegia from cervical spinal cord injury. The regulator describes it as the world’s first invasive BCI medical device to reach the market. The approval used the NMPA’s fast-track route for innovative devices.
Announcement No. 24 (2026), issued on 29 June 2026, fixed the classification rules. Every invasive or implantable BCI is Class III. Non-invasive BCIs are Class III by default, with Class II reserved for non-invasive stroke motor rehabilitation devices that use no artificial intelligence. Products sold for non-medical use must say so on their labels and cannot claim to improve or restore nervous system function.
On 19 August 2026 the NMPA cleared a non-invasive EEG cap from Tianjin-based Tiankai Suishi for cognitive-impairment assessment. On 14 September 2026 it issued a standard on the quality of EEG datasets used by AI algorithms in BCI medical devices, effective 1 September 2027.
Latest
StairMed’s implantable wireless system entered the NMPA’s special review procedure for innovative devices in November 2025, with a market target of around 2028. NeuroXess’s Triple-Full system entered the same programme in July 2026. Neither has a registration decision.
Why it matters
Between March and September 2026 the NMPA gave BCI developers an approved precedent, a classification rulebook and a data-quality standard. Any foreign company filing in China now knows its implant will be reviewed as Class III.
Coverage on InsideBCI
- 13 March 2026: China Grants First Commercial Approval for an Implantable Brain-Computer Interface
- 4 July 2026: China’s NMPA locks BCI device classification: every implant is Class III, one narrow Class II lane
- 3 September 2026: NMPA clears Tiankai Suishi’s non-invasive EEG cap for cognitive-impairment diagnosis
- 17 September 2026: China issues a medical-device standard for AI processing of EEG data in brain-computer interfaces
- 2 October 2026: NeuroXess participant uses his brain implant to steer AI from sketch to 3D-printed figurine