NMPA Issues Brain-Computer Interface Medical Device Classification and Naming Guidelines

The National Medical Products Administration (NMPA) officially released two landmark documents on June 30, 2026 – the Guiding Principles for Classification of Brain-Computer Interface Medical Devices and the Guiding Principles for Generic Naming of Brain-Computer Interface Medical Devices (Announcement No. 24 of 2026). Both guiding principles take effect immediately upon issuance.

Key Takeaways:

BCI Medical Device Definition: Active medical devices 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 assistive or therapeutic devices, with the clinical effect of improving, restoring, or replacing central nervous system functions.

Classification Rules:

Invasive/Implantable → Class III (Classification Code: 12‑00)

Non‑invasive (for disease treatment / functional compensation) → Class III (09‑00 / 19‑00)

Non‑invasive (for stroke rehabilitation, without AI) → Class II (19‑00)

Generic Naming Convention: The name follows the structure "Feature 1 + Feature 2 + Feature 3 (if applicable) + Core Term". Example: "Implantable Brain‑Computer Interface Hand Motor Function Compensation System".

Important: Products intended for non‑medical purposes – such as functional enhancement, entertainment interaction, or daily assistance – are NOT regulated as medical devices.

On Product Counts: As of the issuance of this announcement, the NMPA has not yet published specific statistical data on the number of domestic and imported BCI medical device registrations. According to publicly available information, Neuracle Technology's "Implantable Brain‑Computer Interface Hand Motor Function Compensation System" received NMPA approval in March 2026, becoming the world's first commercially approved invasive BCI medical device. Earlier reports indicated that as of the end of 2025, China's NMPA had approved 5 BCI medical device registration certificates in total.