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National medical device review meeting was held in 2016

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In September 22nd, the national medical device review meeting was held in Hangzhou, Zhejiang. Jiao Hong, deputy director of the State Food and drug administration, attended the meeting and delivered speeches.


The meeting summed up the year national medical equipment review, research and analysis of medical review and approval system reform situation, explore the deepening reform measures evaluation system, put forward the request to the next stage of medical review.


Jiaogong pointed out that in August last year, the State Council issued the "on the reform of drug and medical device review and approval system of opinions", the State Food and drug administration to thoroughly implement the reform opinion, issued a "comprehensive reform of medical device evaluation center" scheme, optimization review mode and process, accelerate the innovation of medical equipment evaluation, strengthen the evaluation of the ability construction continuously improve the level of scientific evaluation. In the case of less personnel and heavy tasks, the review organizations in all parts of the country will take effective measures to effectively perform their duties. Countries and provinces (autonomous regions and municipalities) medical device review and approval system has gradually improved, the work has taken a new step.


Jiao Hong stressed that the medical equipment technical evaluation work is to protect the public safety source access link, high social concern, the impact on the industry. At the same time, medical robots, mobile medical equipment, high throughput genetic diagnosis, 3D printing and other new technologies, new products, emerging, the ability to review the review also put forward higher requirements. Facing the new situation and new tasks, to rely on force, bold innovation, and constantly improve the evaluation system of medical equipment, medical equipment and improve the ability to review the level of.


Jiao Hong requirements, the State Council on the reform of the pharmaceutical and medical device review and approval system, a series of major decisions, shows that the Party Central Committee and the State Council on the protection of public safety and safety of drug use. The food and drug supervision system should thoroughly study and understand the requirements of the CPC Central Committee and the State Council on to ensure food and drug safety, to strengthen the "Four Consciousness" of the understanding of the medical device review work on the protection of public safety in the act, contribution and play. To further implement the reform of the State Council, to further promote the reform of the review mechanism, and constantly improve the effectiveness of the review. Must resolutely implement the central government on the reform of food and drug regulatory system requirements, in accordance with the functional positioning of public safety allocation of resources, to further establish and improve the review body. To establish a systematic, standardized, professional and systematic training system, and comprehensively enhance the ability and level of the review team. We must continue to promote the construction of a clean government, build a team for the people, pragmatic and honest evaluation team.


At the meeting, Kong Fanpu, director of the General Administration of medical equipment technical review center for work report, Chinese Academy of engineering, South China University of Technology President Wang Yingjun made a biomedical materials research and development of the special report. General Administration of medical device registration management division of the person in charge of the medical device registration management and review of the system of examination and approval of the work of reform. General Administration of organs and related units on behalf of the provincial medical device technical review agencies (corresponding units) and the relevant personnel to participate in the meeting.

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