State Food and Drug Administration held a symposium on the supervision of medical devices in some provinces and cities
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Last Update: 2013-07-29
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Source: Internet
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Author: User
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In order to further strengthen the supervision of medical devices, widely listen to opinions and suggestions, and exchange work experience, from July 23 to 24, 2013, the State Food and Drug Administration held a symposium on the supervision of medical devices in some provinces and cities in Zhejiang Province, at which Comrade Jiao Hong attended and addressed Jiao Hong listened to the report on the experience of medical device supervision in Zhejiang Province, Beijing, Shandong Province and Sichuan Province and the opinions and suggestions of participating provinces on medical device supervision Jiao Hong pointed out that the CPC Central Committee, the State Council and the General Administration attached great importance to the safety of medical devices In this institutional reform, the General Administration strengthened its supervision before and after the medical devices went on the market At the same time, the rapid development of medical equipment industry and the continuous improvement of people's demand for equipment also put forward higher requirements for supervision Jiao Hong stressed that the following work should be done well in the next stage The first is to further clarify and improve the regulatory thinking of medical devices The State Administration will make top-level design and institutional arrangements, summarize and discover local typical cases, and set up demonstration in combination with China's national conditions, international experience and industry development laws All localities should also take a long-term and serious plan, and work out the work plan of medical device supervision in combination with local conditions, so as to promote industrial development and ensure the safety of people's use of devices Second, further consolidate the regulatory basis of medical devices The State Administration will promote the formulation and revision of the regulations on the supervision and administration of medical devices and supporting documents, strengthen the basic work of standards, classification, naming and coding, and speed up the information construction All localities should increase investment in medical device safety, improve technical support system, strengthen grass-roots supervision capacity building, improve supervision and law enforcement conditions, improve scientific supervision level, establish supervision force matching with industrial development, and make up for weak supervision capacity as soon as possible In order to improve the registration management system, the General Administration of the people's Republic of China should strengthen the business guidance to the provincial bureaus, unify the evaluation scale, standardize the order of evaluation and approval, the provincial bureaus should strengthen the supervision and inspection to the local and municipal bureaus, and promote the standardization and standardization of the registration management Third, implement safety responsibility and promote social co governance We should do a good job in system inspection, credit rating evaluation and other work, and implement the main responsibility of enterprises as the first responsible person; we should enrich and strengthen grass-roots regulatory forces, and earnestly implement regulatory responsibility; we should organize and carry out activities such as the quality of medical device manufacturing enterprises, etc., give full play to the role of industry associations and academic groups, and promote the formation of a social governance regulatory pattern During the meeting, Jiao Hong also investigated Zhejiang medical device inspection institute, Zhejiang medical device adverse reaction monitoring center and other technical support institutions The Department of medical device registration and management, the Department of medical device supervision, and the technical evaluation center of medical devices of the general administration are mainly responsible for participating in the meeting and accompanying the investigation.
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