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Food and Drug Administration of Shenzhen Municipality Held 2018 Shenzhen Medical Equipment Managemen

Source: Shenzhen Market and Quality Supervision and Admini
55
2018-04-23
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In order to further strengthen the management of medical equipment in our city, implement the spirit of the work meeting of the State General Administration and the Provincial General Administration, publicize the relevant laws and regulations, and ensure the quality and safety of medical equipment, the Food and Drug Administration of Shenzhen Municipality held the 2018 Shenzhen Medical Equipment Management Meeting on April 19. Representatives of more than 480 medical device production, operation and use units under key supervision of our municipality attended the meeting. Wu Bing, the member of the party group of the Market and Quality Supervision Commission of Shenzhen Municipal and the director of the Bureau of Market Inspection Bureau, attended the meeting.


The meeting conveyed the spirit of the work meeting of the State General Administration and the Provincial General Administration, reported the whole chain supervision working of medical equipment production, operation, use, inspection, testing and adverse reactions monitoring in 2017, deeply analyzed the problems found in the supervision, and put forward the requirements for further strengthening the management of medical equipment.


Director Wu Bing pointed out in his speech that after many years of development, the medical equipment industry in our city has broken their own place, the overall development of the industry has taken the lead in the country and it has become an important part of the high-tech industry in the city. Hope all enterprises will continue to speed up the research and development of innovative products, break the monopoly of foreign products, let consumers use more high-tech products produced by the enterprises in China, and promote the sound development of the medical equipment industry. At the same time, with the continuous improvement of the medical equipment regulations in China and the establishment of the regulations supervision system covering all aspects and links of medical equipment industry, enterprises must further strengthen the implementation of the main responsibility, take laws and regulations as the basic criteria for production, operation and use, optimize and improve the quality management system, and continue to enhance the awareness of responsibility, integrity and legal system. Director Wu Bing stressed: First, we should definite the main responsibility and deepen the implementation of the main responsibility of medical equipment enterprises. The production, operation and use of medical equipment enterprises should have a profound understanding of the situation and background of the medical equipment industry, strengthen the study of laws, regulations and documents, firmly establish the consciousness of “enterprise is the first responsible person of product quality and safety”, and definite the main responsibility of the enterprise. The enterprise should be responsible for its own products and the health of the people. Second, we should strengthen supervision and strengthen supervision over the whole life cycle of medical equipment. The supervision administration should continue to strengthen supervision, expand the scope of supervision, adhere to the requirements of punishing people, and crack down on illegal acts. The supervision administration should strengthen guidance and support to the industry and promote the development of the industry while enhancing the deterrent force of law enforcement. Third, we should focus on innovative research and development, and enhance the competitiveness of the medical equipment industry. The medical equipment industry should seize the historical opportunity of the country to develop high-tech industries and accelerate the replacement of domestic equipment, strengthen innovative research and development, speed up the process of listing innovative products, and further enhance the competitiveness of the medical equipment industry in the city.


深圳市食品药品监管局召开2018年全市医疗器械管理工作会议

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