In January 15, 2014, the State Food and drug supervision and administration of Medical Devices Regulatory Bureau organized the security situation analysis of medical equipment, the country's 8 provinces (city), 7 Administration Bureau related departments and directly affiliated institutions, 9 related industry associations and societies, 9 production enterprises and 5 universities and research institutions, experts and inspection representatives attended the meeting.
Meeting around the production, management, use of links and adverse event monitoring, seriously find the outstanding problems in the medical device industry, profound analysis of the causes of the problems, proposed to further strengthen the supervision of the suggested measures. The conference thinks, according to the daily supervision, medical complaint report, adverse event monitoring, risk monitoring and public opinion monitoring situation, last year the security situation of medical equipment in China is stable on the whole good, not great quality safety events throughout the year, but also exists some problems and weak links.
The meeting stressed, medical device supervision work in 2014 to "security" as the central task, by the laws and regulations construction and ability construction as the key point, to lay a solid foundation, perfect laws and regulations, strengthening support, perfect the system, strengthen supervision, and comprehensively promote the "Twelfth Five Year Plan", using the risk management methods of scientific transport, explore the establishment of classification management system high risk products, strengthen supervision, to carry out the medical devices "five rectification" special action, vigorously promote open and informatization construction, and constantly improve team quality ability, further enhance the scientific level of medical supervision. Meeting the requirements of the food and drug regulatory departments at all levels should closely focus on the safety and effectiveness of medical devices regulatory objectives, conscientiously perform their duties, innovate the working style, strengthen the supervision of high-risk products, focus on the establishment of long-term supervision mechanism of perfect, perfect each regulations system, constructing the effective technical support system and risk control system