According to the official website of the State Food and Drug Administration, from January 18 to 19, 2022, the State Food and Drug Administration organized a special meeting on medical device standard management. Xu Jinghe, a member of the Party Leadership Group and Deputy Director of the State Food and Drug Administration, called for accelerating the improvement of the medical device standard system, benchmarking against international standards, and using powerful means to promote the high-quality development of medical device standards.
The meeting fully affirmed the remarkable achievements of medical device standardization in optimizing the standard system, improving the organizational structure, assisting epidemic prevention and control, improving standard quality, and in-depth implementation of international standardization.
Xu Jinghe requested that medical device standardization work must conscientiously implement the spirit of the National Standardization Work Conference and the “Opinions of the State Food and Drug Administration and the National Standardization Management Committee on Further Promoting the High-Quality Development of Medical Device Standardization Work.”
First, we must speed up the improvement of the medical device standard system. Strengthen the supply-side reform of standards, closely track scientific and technological progress and industrial development, closely track regulatory practice needs, adhere to a problem orientation, benchmark against international standards, and use powerful means to promote the high-quality development of medical device standards.
The second is to continuously improve the standardization work operating mechanism. It is necessary to adhere to the working model of state leadership, business entities, and social participation, establish and improve a working mechanism that encourages all parties in society to participate extensively in the formulation and revision of medical device standards, strengthen management and coordination of all parties, and continuously improve the endogenous motivation of standardization work.
The third is to vigorously promote the formulation and revision of medical device standards. The Device Registration Department must work with the Standards Management Center to strengthen top-level design, strengthen the overall management of the standards system, establish and improve the standard implementation evaluation mechanism, and make dynamic adjustments to standards in a timely manner to better meet the actual needs of industrial development and supervision. Further improve the assessment and evaluation mechanism of the Standardization Committee, conduct comprehensive assessment and evaluation, and strengthen the application of assessment and evaluation results.
The fourth is to increase the publicity of standards. Strengthen standards information disclosure work to better help enterprises learn standards, implement standards, and carry out production and operation activities in strict accordance with laws, standards, and norms.