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The development and revision of industry standards will be completed within this year.

Release time：2020-08-12

　　Recently, the National Medical Products Administration reported that China has continuously strengthened foundational work such as the development and revision of medical device standards, and that the Administration will now undertake systematic planning for the establishment of a comprehensive medical device standards system.

　　In recent years, the State Food and Drug Administration has continuously intensified its efforts in the development and revision of medical device standards, resulting in a significant increase in the number of standards and an ever-expanding scope of coverage. By the end of 2012, China had 1,051 active medical device standards, including 187 national standards and 864 industry standards.

　　In 2013, the Administration will continue to strengthen research on the medical device standards system and ensure the effective development and revision of standards. The Medical Device Regulatory Division of the Administration, in collaboration with the Medical Device Standards Management Center, will conduct research based on a unified framework for medical device standards management, aligning with the needs of industry development and leveraging the resources and expertise of relevant departments to systematically plan the construction of the medical device standards system. Furthermore, the Administration will continue to carry out, according to the annual plan, the development and revision of 105 industry standards for medical devices.

　　In addition, management requirements for the development and revision of medical device standards—including research on reference materials—will be formulated; project implementation will be rigorously guided and supervised; and review and publication procedures will be carried out in a timely manner.

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