China Raises Clinical Entry Bar for Brain-Computer Interfaces, Delineating Medical and Consumer Applications

Two new guidelines have ended the long-standing lack of unified classification and nomenclature standards in the brain-computer interface (BCI) field, providing clear product definitions and regulatory submission pathways for the industry, while also laying the institutional groundwork for subsequent steps such as medical insurance reimbursement and hospital procurement.

On July 7, NeuroXess, a Shanghai-based brain-computer interface (BCI) company, announced the official launch of Good Clinical Practice (GCP) registration clinical trials for its self-developed “Implantable Brain-Computer Interface System for Compensatory Hand Motor Function” (hereinafter referred to as the “Sanquan” BCI) at Huashan Hospital Fudan University. Entering GCP registration clinical trials marks a critical step for a medical device in transitioning from scientific exploration to large-scale clinical application.

According to reports, this newly launched clinical study will evaluate the safety and efficacy of the “Sanquan” brain-computer interface in compensating for upper limb function in patients with quadriplegia resulting from cervical spinal cord injury. Data from this GCP-registered clinical trial will be directly used for the Class III medical device registration application with the National Medical Products Administration (NMPA), representing a critical milestone prior to product market approval.

Notably, this marks the first clinical study on brain-computer interfaces (BCIs) initiated following the recent issuance by the National Medical Products Administration (NMPA) of two new regulations: the “Guiding Principles for the Classification and Definition of Brain-Computer Interface Medical Devices” and the “Guiding Principles for the Generic Naming of Brain-Computer Interface Medical Devices.” According to these new guiding principles, a brain-computer interface medical device is defined as an active medical device that measures neural signals generated by the central nervous system via invasive or non-invasive methods and decodes them in real time, thereby enabling real-time bidirectional interaction or closed-loop feedback between the patient and external assistive or diagnostic/therapeutic devices, with the aim of achieving clinical outcomes such as the improvement, restoration, or substitution of central nervous system functions.

“The two new guidelines have put an end to the long-standing lack of unified classification and nomenclature standards in the field of brain-computer interfaces, providing the industry with clear product definitions and regulatory submission pathways, while also laying the institutional groundwork for subsequent processes such as medical insurance reimbursement and hospital procurement,” said Chen Yuan, Clinical Director at NeuroXess, in an interview with Yicai Global.

Chen Yuan stated that the new regulations clearly stipulate that invasive/implantable products are uniformly managed as Class III medical devices. The “Three-Alls” brain-computer interface (BCI) technical route is highly consistent with the regulatory positioning of invasive/implantable medical devices under the new rules, thereby providing all industry practitioners with clear regulatory expectations.

Class III medical devices, representing the highest risk category, are subject to stringent requirements for research and development, clinical trials, and regulatory registration. “Including invasive brain-computer interface products under Class III medical device regulation helps establish high entry barriers and concentrate resources on leading enterprises that have accumulated clinical data and possess clear regulatory pathways,” stated Chen Yuan.

The new regulations also clarify that brain-computer interface (BCI) products categorized as “function-enhancing,” “entertainment-interactive,” or “daily-assistive” will not be regulated as medical devices, thereby drawing a clear line between consumer-grade and medical-grade products. “This means that consumer-grade BCI products can be marketed without undergoing medical device registration and approval by the National Medical Products Administration (NMPA), but it also means they cannot claim any therapeutic effects,” Chen Yuan told a reporter from Yicai. “The market positioning for truly clinically valuable, medical-grade products is now much clearer.”

Currently, the brain-computer interface (BCI) industry is transitioning from conceptual hype to the product validation phase. Taking spinal cord injury (SCI) as an example, according to the "2023 Report on Quality of Life and Disease Burden among Individuals with Spinal Cord Injury in China," there are currently over 3.7 million patients in China, with approximately 90,000 to 100,000 new cases annually. For patients with complete SCI, there is virtually no potential for further neurological recovery under traditional rehabilitation therapies. In the current medical landscape, brain-computer interfaces represent the core technological pathway for achieving functional reconstruction in this patient population.

Peng Lei, Founder and CEO of the ultrasound-based brain-computer interface (BCI) company Gestalt, stated in an interview with a Yicai reporter last week that the development path of Gestalt’s BCI products will begin with serious medical devices, gradually evolve into home-use medical devices, and then advance to consumer-grade electronic products. The company expects to obtain its first Class III medical device registration certificate in the first half of 2028.