The National Standardization Working Group for Intelligent Medical Devices has been approved

1、 Fill the industry gap and build an authoritative standard system

With the deep integration of artificial intelligence, robotics technology, and the healthcare industry, the intelligent medical device industry has entered a period of rapid development. However, the problem of the lack of relevant standards and lagging norms has become increasingly prominent, becoming a bottleneck restricting the development of the industry. The National Standardization Working Group for Intelligent Medical Devices, which has been approved for establishment this time, was born to address this pain point. It is the first standardization technology organization in China specifically focused on the field of intelligent medical devices, ending the history of no dedicated standardization coordination organization in this field.

The core responsibilities of the working group are clear, and they will be fully responsible for the standardization of artificial intelligence medical devices, medical robots, brain computer interface medical devices, and fusion technology medical devices, including the development of national standards, industry standards, standardization of technical terminology, product performance, safety requirements, clinical trial methods, and other key content. Through systematic layout, a comprehensive, scientifically standardized, and internationally aligned standard system will be established to provide a unified basis for product research and development, production and manufacturing, inspection and testing, clinical application, and market supervision, and to solve the industry's dilemma of "no standard to follow".

2、 Focusing on cutting-edge tracks, escorting the landing of innovative technologies

Intelligent medical devices are the core track of global medical technology competition. Technologies such as artificial intelligence assisted diagnosis, surgical robots, and brain computer interfaces are rapidly moving from laboratories to clinical settings, reshaping the healthcare service model. The establishment of the working group precisely aligns with the national strategy and urgent needs of industrial development, conforms to the trend of deep integration of new technologies and medical devices, and focuses on three cutting-edge fields.

In the field of artificial intelligence medical devices, standards for algorithm model development, data quality control, algorithm safety and reliability evaluation will be standardized to ensure the clinical effectiveness and safety of AI assisted diagnosis, intelligent image analysis and other products. In the field of medical robots, standards for mechanical performance, control accuracy, safety protection, electromagnetic compatibility, etc. are formulated for surgical robots, rehabilitation robots, nursing robots, etc., to improve product stability and compatibility. In the field of brain computer interfaces, as a multidisciplinary frontier, it will fill the standard gaps in terminology definition, technical architecture, EEG dataset quality, implantation safety, etc., and assist in the application of brain computer interfaces in paralysis rehabilitation, neurological disease treatment and other scenarios, consolidating China's international leading advantage in this field.

3、 Empowering industrial upgrading and enhancing international competitiveness

Standardization is the "passport" for high-quality industrial development and the core competitiveness for participating in international competition. In recent years, China's intelligent medical device industry has developed rapidly. By 2025, the number of approved innovative medical devices will increase by 17% year-on-year. Technological breakthroughs in fields such as brain computer interfaces and medical robots continue to occur, and the market size will continue to expand. However, due to the imperfect standard system, some products have problems such as uneven quality, low technical barriers, and insufficient international recognition, which restrict the scale and internationalization development of the industry.