Standards promote the high-quality development of medical devices China Medical Device Standards Forum held in Beijing

  • 2021-10-15
October 14, this year, is the 52nd World Standards Day, with the theme "Standards for sustainable development and a better world". On October 14, China Medical Device Standards Forum- 2021 "World Standards Day" medical device standardization theme event was held in Beijing under the guidance of the Medical Device Registration and Administration Department of State Drug Administration and hosted by the Medical Device Standards Management Center of State Drug Administration. The theme of the forum is "Standards promote the high-quality development of medical devices", aiming to further promote the concept of standardization of medical devices, and better play the role of standards to support the supervision of medical devices and the high-quality development of the industry.
   Medical device standards run through all aspects of the life cycle of medical device management activities, which is crucial to keep the bottom line to ensure safety, and pursue high line to promote development. In recent years, State Drug Administration has continuously deepened the reform and innovation of medical device standardization, constantly improved the standardization system of medical devices, scientifically formulated the work plan for standardization of medical devices, further promoted the plan of standardization of medical devices, unceasingly bettered standardization of organization system, and incessantly strengthened the international exchange and cooperation on standardization of medical devices, which has strongly supported the supervision of medical devices and the development of the industry. Up to now, the total of China's current medical device standards is 1835, of which there are 233 national standards, 1602 industry standards, 393 mandatory standards and 1442 recommended standards, basically covering all professional technical fields of medical devices; At the same time, the recognition of international standards project by international medical device regulatory is unanimously recognized by all IMDRF members so that the conversion rate of China's medical device standards international standard is more than 90%. In August this year, the first international standard project for epidemic prevention and control medical devices proposed and completed by our country, Medical Electrical Equipment Part 2-90: Special Requirements for Basic Safety and Essential Performance of High Flow Respiratory Therapy Equipment, was released by the International Organization for Standardization and the official website of the International Electrotechnical Commission.  

  In October this year, the Central Committee of the Communist Party of China and the State Council issued the Outline for the Development of National Standardization, which makes strategic deployment for the development of national standardization.  In March this year, State Drug Administration, together with the State Standards Commission, issued the Opinions on Further Promoting the High-Quality Development of Medical Device Standardization, which clearly defined the development goals and programmatic requirements of medical device standardization in the new development stage. In order to implement the development and deployment of medical devices standardization and promote the high-quality development of the industry, the head of the Device Registration Department of State Drug Administration said that in face of the new situation and tasks in the new stage of development, the standardization of medical devices must have new initiatives to achieve new breakthroughs. First, we should implement the decision-making and deployment of the Party Central Committee and the State Council on the reform of standardization work, do a good job in the top-level design of medical device standardization work, and constantly improve the standard management system and working mechanism of medical equipment. Second, we should better lead the high-quality development of the medical device industry, focus on new technologies, new materials and new products, further promote the reform of standardization of medical devices, strengthen standard research in key areas, and promote industrial optimization and upgrading. Third, we should better serve the high-quality development of medical device supervision, promote the deep integration of standardization work and scientific and technological innovation, and penetrate standardized concepts, standardized thinking and standardized methods into all aspects of the life cycle of medical devices. Fourth, we should form a situation of social co-governance in the standard field, and promote the formation of a standardized common governance pattern of medical devices with government supervision, business owners' responsibilities, industry self-discipline and social coordination. Fifth, we should deepen international exchanges and cooperation on medical device standards, actively transform international standards for medical devices suitable for china, and provide China's program for the standardized development of medical devices worldwide.

  During the thematic reporting, the relevant person in charge of the Mandatory Standards Management Department of the Standards and Technology Division of the General Administration of Market Supervision explained in detail the spirit of the National Standardization Development Program and the construction of the mandatory national standard system. The head of the Registration Research Office of the Equipment Registration Department of State Drug Administration read in depth the Opinions on Further Promoting the High-Quality Development of Medical Device Standardization. Jiang Feng, executive vice president of the China Medical Device Industry Association, shared his thoughts on how medical device standards drive innovation in the industry and enterprises. Professor Qiu Jie of Beijing Concord Hospital explained the importance of medical device standards for clinical safety. Chen Wei, founder of Beijing YiHe JiaYe Medical Technology Co., Ltd made a thematic report on the high-quality development of medical device standards to enhance the competitiveness of enterprises.

  At the forum, the China Medical Device Industry Association released the first batch of 10 medical device standards implementation benchmark enterprises.

  Relevant principals of relevant departments and bureaus of State Drug Administration, Standard Management Center, News Center, Media Group, as well as relevant principals of National Standardization Management Committee, China Drug Regulatory Research Association, expert representatives of China Medical Device Industry Association, China Society of Biomedical Engineering, China Society of Biomaterials and representatives of various medical device standardization (sub) technical committee and standardization technology export units, medical device enterprises, etc. attend the main conference. On the same day, the International Electrotechnical Commission - Medical Electrical Equipment Technical Committee, the National Medical X-ray Equipment and Appliance Standardization Sub-Technical Committee held the 7th IEC International Medical Device Standards Forum on the theme of "Medical Device Standards in the Age of Innovation and Technology" at the Shenzhen Branch.

      Source: State Drug Administration