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Medical Device Supervision Division held a medical device security situation analysis

Date:2017-10-24

January 15, 2014, the State Food and Drug Administration Medical Device Supervision Division held a meeting on the analysis of the safety situation of medical devices to jointly analyze the security situation of medical devices to find the quality and safety risks and regulatory weaknesses existing in the medical device industry, the study proposed further Strengthen medical equipment supervision and management measures.


The meeting stressed that in 2014, the supervision of medical devices should focus on "security and safety", focus on the construction of laws and regulations and capacity building, focus on laying a solid foundation, improving laws and regulations, strengthening support, improving the system, strengthening supervision and comprehensively promoting "12 Five "plan, scientific use of risk management methods, explore the establishment of hierarchical classification management system, strengthen the supervision of high-risk products, focus on medical equipment," five remediation "special action, vigorously promote the open government and information technology, and continuously improve the quality of the team, further Improve the level of scientific supervision of medical devices. The meeting called for the food and drug regulatory authorities at all levels to focus on the safe and effective regulatory targets for medical devices, conscientiously perform their duties, innovate their working methods, intensify the supervision of high-risk products, strive to establish a sound long-term regulatory mechanism, improve various rules and regulations, Build effective technical support system and risk prevention and control system.


The meeting conscientiously searched for outstanding problems in the current medical device industry, thoroughly analyzed the reasons for the problems, and put forward suggestions for further strengthening supervision in the areas of production, operation, use and monitoring of adverse events. According to the meeting, the safety situation of medical equipment in China was generally stable and steady in the past year according to the daily supervision of medical equipment, complaint reporting, adverse event monitoring, risk monitoring and public opinion monitoring. No major quality and safety incidents occurred during the year, but there were also some prominent Problems and weaknesses.


Experts and representatives from 8 provincial (city) bureaus, 7 relevant bureaus and subordinate units of the State Council, 9 related trade associations and institutes, 9 production and operation enterprises and 5 institutions, inspection and research institutions attended the meeting.

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