National Medical Products Administration

The reporter learned from the State Drug Administration that China has continued to implement the action plan to improve medical device standards, focusing on supporting the development of standards for high-end and innovative fields such as artificial intelligence medical devices and new biomedical materials and endeavoring to fill the gaps in standards for creative fields. Medical device standards have reached 1978. Among them, 272 national standards, 1,706 industry standards, 269 mandatory standards, and 1,709 recommended standards cover all professional and technical fields of medical devices.

China has actively set up medical device standardization technical organizations in recent years, and the standard organizational structure is constantly improving. Medical robotics, artificial intelligence medical devices, medical equipment industry and applications, Chinese medicine devices, and other standardization organizations have been established; medical device standardization organizations have reached 39, basically building a horizontal to the side, vertical to the end, vertical support of the standard organization system.

At the same time, the degree of consistency between China's medical device standards and international standards has reached 95%, and the international discourse on standards has been steadily improving. 2023 Since then, two international standards developed by our country have been successfully released, and formulating and revising five international standards has been orderly promoted. International standards such as 'Performance test method for algorithms of lung image assisted analysis software for artificial intelligence medical devices' have been successfully established, reflecting China's commitment to enhancing the quality and safety of medical devices, fostering innovation in the healthcare sector, and aligning more closely with global practices to ensure that Chinese medical devices meet the rigorous standards expected in international markets while also addressing domestic healthcare needs effectively.

This proactive approach bolsters domestic capabilities and positions China as a significant player in the global medical device industry, paving the way for future advancements and collaborations in health technology.