Providing a unified and authoritative “common language” – China’s first medical device standard for brain-computer interfaces released

The National Medical Products Administration recently approved and issued the industry standard “Terminology for Medical Devices Using Brain-Computer Interface Technology”, which will be officially implemented on January 1 next year.

How to precisely define the cutting-edge concept of “brain-computer interface”

Li Shu, Researcher at the Institute of Medical Devices, National Institutes for Food and Drug Control, and Drafter of the Standard: During the drafting of the standard, the biggest challenge we faced was how to accurately define the cutting-edge concept of “brain-computer interface”. Brain-computer interface medical devices involve multiple disciplines such as clinical medicine, neuroscience, and computer science, and the expression of the same concept may vary across different disciplines.

Hu Sheng, Standard Drafter at Shanghai Institute of Medical Device Testing :Regarding this basic concept, we also went through multiple rounds of repeated discussions and finally clarified that it is a type of medical device. It can perform real-time decoding and deciphering of neural signals generated by the central nervous system, help patients achieve real-time two-way information interaction or closed-loop feedback with external auxiliary or diagnostic and treatment equipment, thereby improving, repairing, or replacing some of the patient’s physiological functions.

Experts told reporters that the newly introduced standards have clarified the basic concepts of brain-computer interface medical devices, covering core terms such as paradigm types, signal forms, signal processing, and applications. These standards provide a unified and authoritative “common language” for product research and development, production inspection, registration evaluation, and supervision.

Hu Sheng, Standard Drafter at Shanghai Institute of Medical Device Testing :We have considered both the technical forms and characteristics of invasive brain-computer interface technologies that have already entered clinical practice, and at the same time, we have left room for concepts that are still in the research stage, such as interventional brain-computer interfaces, to allow for technical development space when such concepts are put into clinical and medical use in the future.

It is understood that this standard, which was formulated and released by the National Medical Products Administration through an accelerated process with shortened project initiation time, leads internationally.

Stepping up the development of a number of related standards

Launching supporting policies

Reporters learned that in addition to the first standard that has already been issued, the National Medical Products Administration is currently accelerating the project approval and formulation of multiple relevant standards through an expedited process, focusing on the research and development of the application of brain-computer interfaces in the medical field. It is also introducing supporting policies to facilitate the high-speed development of the brain-computer interface medical device industry.

Zheng Jia, Deputy Director of the Institute of Medical Device Standards, National Institutes for Food and Drug Control, and Standard Reviewer: In addition to the standard “Terminology”, three other standards for brain-computer interface medical devices have currently been approved for project initiation and formulation through an accelerated process. Key focuses include “closed-loop implantable neurostimulators”, “electroencephalographic datasets for artificial intelligence algorithms”, and “motion intention encoding and decoding performance”. Among them, the industry standard for “closed-loop implantable neurostimulators” is to be released in the coming days.

In addition, the National Medical Products Administration recently established a working group for standard system research and put forward a list of relevant standards that should be prioritized for formulation in the next 3 to 5 years.

Zheng Jia, Standard  Reviewer， Deputy Director at the Institute of Medical Device Standards, National Institutes for Food and Drug Control： Currently, the members of the working group mainly consist of experts from various fields such as the research and development, production, clinical application, inspection and testing, technical evaluation, and supervision of brain-computer interface medical devices. The working group plans to formulate subsequent standard development plans, striving to cover the entire life cycle management of brain-computer interface medical device products.

The scale of China’s brain-computer interface will exceed 6 billion yuan in 2028 

Driven by both policy promotion and technological breakthroughs, China’s brain-computer interface market is entering a period of rapid growth. By 2028, the scale of China’s brain-computer interface market will exceed 6 billion yuan.The compound annual growth rate from 2024 to 2028 is projected to be 17.7%.The global market size of brain-computer interfaces in medical applications is expected to reach 40 billion US dollars by 2030 and may reach 145 billion US dollars by 2040.

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Source： NMPA
Translated & edited：Bradyknown