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Summary of the conference on publicity, implementation and interpretation of regulations on supervision and administration of medical devices

Source: administrator

In June 2021, Beijing Pharmaceutical Industry Association organized a conference on the publicity, implementation and interpretation of the regulations on the supervision and administration of medical devices. The content of this meeting is highly professional and closely related to the future development of our company. Therefore, we will summarize the key points of this meeting in the form of words.



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Four experts were invited to interpret the new regulations from four different aspects.



Service function exhibition of Beijing Pharmaceutical Industry Association


Xia liming, an expert of Beijing Pharmaceutical Industry Association, introduced the basic situation, functions and service items of the association, and pointed out that the association should strive to provide four services: service enterprises, service industry, service government and service society.

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Implement reform measures and encourage new development of the industry



Lu Aili, former deputy director of Beijing food and drug administration, pointed out: the new regulations support the innovation and development of medical devices, and encourage the innovation and development of medical devices through commendation and reward, policy support, improvement of innovation system, priority approval, adjustment of punishment and system construction.


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Progress in the construction of regulatory system for medical devices in China



Progress in the construction of China's medical device regulatory system This paper combs the process of the construction of China's medical device regulatory system from four aspects: the key points of the revision of the medical device regulatory regulations and the prospect of the construction of China's medical device regulatory regulations, and mainly explains the key points of the revision of the medical device regulatory regulations from the aspects of basic principles, leadership responsibility, system guarantee, evaluation and review.


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New strength of good medical workers


Jin Dong, President of China Medical equipment magazine, first analyzed the development trend of China's medical device industry, analyzed the challenges faced by China's medical device industry in the current world environment, and elaborated the new stage and ten development trends of China's medical device industry under the epidemic situation. Secondly, this paper analyzes the satisfaction and net recommended value of domestic brands in China's medical equipment industry in recent years. Finally, it summarizes the data advantages and service quality of "good medical workers".


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The newly revised "Regulations on the supervision and administration of medical devices" came into effect this month, focusing on four aspects: implementing the reform requirements of the review and approval system of medical devices, further consolidating the main responsibility of enterprises; We should consolidate the reform achievements of "release, management and service", optimize the approval and filing procedures, give priority to the approval of innovative medical devices, release the market innovation vitality, and further reduce the burden of enterprises; Strengthen the supervision of the whole life cycle and the whole process of medical devices to improve the supervision efficiency; We should strengthen the punishment of illegal activities and increase the cost of illegal activities.


Medical devices are directly related to people's life and health. In recent years, with the rapid development of the medical device industry, the CPC Central Committee and the State Council have made a series of major decisions and arrangements on the reform of the drug and medical device review and approval system, consolidated the reform achievements in the form of laws and regulations, further promoted industry innovation from the system level, and better met the people's expectations for high-quality medical devices.


Through this meeting, our staff have a deeper understanding of the regulations on the supervision and administration of medical devices and the market development trend, and also provide a clearer direction for the development of the company.