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A Study On The Construction of Technical Organization for Medical Device Postmarket Monitoring in China

MENG Gang1 LIANG Wan-nian2 LI Shao-li3 WANG Ya-dong2 YAN Min3 CAO Li-ya1 1 Center for Drug Evaluation, SFDA (Beijing 100061) 2 Capital University of Medical Science (Beijing 100054) 3 State Food and Drug Administration (Beijing 100810)  
Objective: To investigate the construction model for medical device postmarket monitoring in china;Method: The combination of qualitative and quantitative analysis were conducted in this study; Results: The long term development objective of the monitoring system of medical instrument and devices adverse effects: establish a monitoring system of medical instrument and devices adverse effects that have the abilities to examine the new problems, measure the change trend of dangerous elements, intervene and evaluate intervention treasures and policy effects according to the working function of the supervision; the internal establishments of the monitoring organization should include policy study department, comprehensive intervention department, regulation implementation department, monitoring evaluation department, propagandizing and training department to cooperate in the work together; Conclusion: At the early stage of the construction of the monitoring organization we set up scientific monitoring concept, draw up effective and feasible specific measures.
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