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The national medical device regulatory work conference proposed deepening reform and Innovation

Date:2014.10 Label:Latest News  Source:Administrator

In 2012 the national medical equipment supervision and management work conference on January 11th ~ 12 day held in chengdu. A comprehensive summary of the meeting of the medical device supervision work in 2011 of 2012, the deployment of medical device regulatory focus of the work, and informed a number of outstanding contribution in the supervision work in the medical appliance units and individuals. Deputy director of the State Food and Drug Supervision Bureau Bian Zhenjia attended the meeting and made a speech.
Bian Zhenjia said, over the past year, medical devices administration has made new progress in the practice of philosophy, science and innovation of supervision and supervision mechanism, strengthen the daily supervision, in a new record in improving supervision efficiency, in the promotion of supervision according to law, a new improved to strengthen supervision on the basis of. While fully affirming our achievements, we should also clearly recognize that, the current medical devices administration is facing many problems to be solved: the supervision of construction of the legal system needs to be further strengthened, "progress" amendment of the regulations on the supervision and administration of medical devices is slow, the relevant supporting regulations and regulatory documents to be perfect, part of the supervision of laws and supervision situation coordination. Regulatory infrastructure needs to be further strengthened, investment funds at the provincial level detection mechanism is not enough, the detection ability of imbalance, analysis of adverse event monitoring institutions monitoring and risk signal ability needs to be improved, the ability of technical support and regulatory requirements do not match. Supervision team construction needs to be further strengthened, medical device supervision personnel supervision departments at all levels to less, unreasonable professional structure, especially the grass-roots weak supervision, supervision team and supervision task does not adapt. Review and approval mechanism needs further deepening reform, from the overall situation of the country, lagging behind the construction of the technical evaluation agency approval, lack of capacity, efficiency is not high, the work is not standardized phenomenon still exists in some areas. On these issues, we must attach great importance to, treat, in-depth study seriously, and resolved in a timely manner.
The medical device supervision work in 2012, side vibration armour, put forward five requirements: strengthen supervision, to ensure the safety of the regulatory mechanism; deepen reform, innovating regulatory mode; pay close attention to the implementation of the work, to ensure the effectiveness of the work; strengthen the research learning, improve the supervision capacity; strengthening the Party style and clean government, set up the system of image integrity.
The provinces (area, city) and Xinjiang production and Construction Corps, municipalities, deputy provincial capital city food and Drug Supervision Bureau, Health Department of General Logistics and drug administration, the national medical equipment quality supervision and inspection center and a total of 72 units of more than 150 delegates.

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