October 14 is the 52nd world standards day, with the theme of "standards promote sustainable development and build a better world". On October 14, under the guidance of the medical device registration administration department of the State Drug Administration and sponsored by the medical device standard management center of the State Drug Administration, the China medical device standard Forum - the theme activity of "world standard day" Medical Device Standardization in 2021 was held in Beijing.
The theme of this forum is "standards boost the high-quality development of medical devices", which aims to further publicize the concept of medical device standardization and give better play to the supporting role of standards in helping the supervision of medical devices and the high-quality development of the industry.
Medical device standards run through the management activities of all links in the whole life cycle of medical devices, which is very important to keep the bottom line, ensure safety and promote development. In recent years, the State Food and drug administration has continuously deepened the reform and innovation of medical device standardization, improved the system of medical device standards and regulations, scientifically formulated the work plan for medical device standardization, deeply promoted the improvement plan of medical device standards, continuously improved the standardization organization system, and continuously deepened the international exchange and cooperation of medical device standardization, It has strongly supported the supervision of medical devices and the development of the industry. Up to now, there are 1835 current medical device standards in China, including 233 national standards and 1602 industrial standards; There are 393 mandatory standards and 1442 recommended standards, basically covering all professional technical fields of medical devices. At the same time, the international medical device regulatory accreditation international standard project has been unanimously recognized by all members of imdrf, and the conversion rate of China's medical device standards to international standards has reached more than 90%. In August this year, the first international standard project for epidemic prevention and control medical devices proposed and completed by China, medical electrical equipment Part 2-90: special requirements for basic safety and basic performance of high flow respiratory treatment equipment, was published on the official website of the international organization for standardization and the International Electrotechnical Commission.
In October this year, the CPC Central Committee and the State Council issued the national standardization development outline to make strategic arrangements for the development of national standardization. In March this year, the State Food and Drug Administration and the National Standards Commission jointly issued the opinions on further promoting the high-quality development of medical device standardization, which defined the development objectives and programmatic requirements of Medical Device Standardization in the new development stage. In order to implement the development deployment of medical device standardization and promote the high-quality development of the industry, the person in charge of the device registration department of the State Food and Drug Administration said that in the face of the new situation and new tasks in the new development stage, there must be new measures and new breakthroughs in the standardization of medical devices. First, we should implement the decision-making and deployment of the CPC Central Committee and the State Council on the reform of standardization, do a good job in the top-level design of medical device standardization, and constantly improve the management system and working mechanism of medical device standards. Second, standards should better lead the high-quality development of the medical device industry, focus on new technologies, new materials and new products, deeply promote the reform of medical device standardization, strengthen the research on standards in key fields, and promote the optimization and upgrading of the industry. Third, we should make the standards better serve the high-quality development of medical device supervision, promote the deep integration of standardization work and scientific and technological innovation, and infiltrate the standardization concept, standardization thinking and standardization methods into all links of the whole life cycle of medical devices. Fourth, we should form a situation of social co governance in the field of standards, and promote the formation of a pattern of standardized co governance of medical devices with government supervision, enterprise responsibility, 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 Chinese solutions for the development of global medical device standardization.
In the theme report, the relevant person in charge of the mandatory standards management office of the standards Technology Department of the State Administration of market supervision explained in detail the spirit of the national standardization development outline and the construction of the mandatory national standards system. The person in charge of the registration and Research Office of the device registration department of the State Food and drug administration deeply interpreted the opinions on further promoting the high-quality development of medical device standardization. Jiang Feng, executive vice president of China Medical Device Industry Association, shared his thoughts on medical device standards promoting the innovation and development of industries and enterprises. Professor Qiu Jie of Peking Union Medical College Hospital expounded the importance of medical device standards for clinical use safety. Chen Bei, founder of Beijing Yihe JIAYE Medical Technology Co., Ltd., made a theme report on the high-quality development of medical device standards and improving enterprise competitiveness.
At the forum, China Medical Device Industry Association released the first batch of 10 benchmark enterprises for the implementation of medical device standards. In addition, the seventh IEC international medical device standards forum with the theme of "medical device standards in the era of innovative technology" was held in Shenzhen at the same time by the International Electrotechnical Commission - Medical electrical equipment technical committee and the national medical X-ray equipment and appliance standardization sub Technical Committee.
Post time: Dec-20-2021