In recent years, the standardization work of medical devices in China has thoroughly implemented General Secretary Xi Jinping's "four strictest requirements", earnestly implemented the National Standardization Development Outline and the 14th Five-Year Plan for National Drug Safety and High-Quality Development, and accelerated the construction of a medical device standard system oriented towards new quality productivity, laying a solid foundation for supporting scientific supervision, facilitating high-tech innovation, promoting high-level opening up, and leading high-quality development.

Adhering to the overall planning of both high-quality development and high-level safety, the standard system has been continuously optimized. The action plan for improving medical device standards has been continuously implemented, the working mechanism has been innovated, the management system has been improved, the optimization and evaluation of mandatory standards and the centralized review of recommended standards have been fully completed, a high-quality standard supply system has been constructed, with a focus on supporting the research and development of standards in high-end and innovative fields such as artificial intelligence medical devices and new biomedical materials, and efforts have been made to fill the gaps in standards in innovative fields. Up to now, the number of medical device standards has reached 1978, including 272 national standards and 1706 industry standards; 269 mandatory standards and 1709 recommended standards, basically covering all professional and technical fields of medical devices.

Adhering to the overall planning for the simultaneous improvement of both quantity and quality, the organizational structure of standards has been continuously improved. With scientific planning and rational layout, active efforts have been made to establish medical device standardization technical organizations for national strategic deployment and innovative fields. Standardization organizations for medical robots, artificial intelligence medical devices, medical equipment industry and application, and traditional Chinese medicine instruments have been established successively. There are now 39 medical device standardization organizations in total, basically forming a standard organization system with horizontal to the edge, vertical to the end, and vertical support.

Adhering to the mutual promotion of domestic and international standards, China's international discourse power on standards has been steadily enhanced. Attention has been paid to establishing a scientific, reasonable and highly efficient international standard transformation mechanism. The consistency degree between China's medical device standards and international standards has reached 95%. Since 2023, two international standards led by China have been successfully released, and the work of formulating and revising five international standards has been progressing in an orderly manner. International standards such as the Artificial intelligence medical device—Computer assisted analysis software for pulmonary images—Algorithm performance test methods have been successfully established. Two Chinese experts have been recommended and elected as the chairman of IEC SC 62B and the vice chairman of TC62 respectively, further enhancing the international influence of China's medical device standards.

In the next step, the NMPA will continue to optimize the medical device standard system, improve the efficiency of standard management, deepen international exchanges and cooperation on standards, accelerate the construction of a medical device standard system oriented towards new quality productivity and promote high-quality development, give full play to the guiding, leading and fundamental roles of standards, and provide strong standard technical support for the high-quality development of medical device supervision and industrial innovation.