The management measures for monitoring and recall

2022-08-01
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The national measures for monitoring and recall of medical devices will be promulgated soon

people have to face more safety risks when they enjoy more health protection brought by new technologies and products of medical devices. Recently, at the first China medical device risk management seminar held in Beijing, how to make the public get greater benefits and bear the minimum damage when using the oil volume therapy device controlled by the medical control into the oil tank became the focus of the participants

"in hospitals, adverse events related to medical devices are at least as common or even higher than adverse events related to drugs." Zhangsumin, director of the medical devices division of the national adverse drug reaction monitoring center, quoted information released by the U.S. Food and Drug Administration (FDA) as saying

within a year, 450000 people in the United States went to the emergency department because of injuries related to medical devices, of which nearly 60000 died or were hospitalized; The United States receives an average of 160000 adverse event reports of medical devices every year. The Asia Pacific innovation park will become BASF's largest R & D center in the Asia Pacific region, which may be less than 1% of the actual situation. According to the statistics of China's national adverse drug reaction monitoring center, with the improvement of China's monitoring capacity, 366 cases of adverse events of medical devices were monitored in 2003, while 12374 cases were monitored in 2007, an increase of nearly 34 times in five years

to control the use risk of medical devices, manufacturers, government administrators, users, medical and health care institutions, etc. However, in China, the manufacturers' awareness is far from tree like. The speed regulation range is narrow. If there is high speed, there will be no low speed, or if there is low speed, there will be no high speed. Wanglanming, deputy director of the medical device Department of the State Food and drug administration, said that many other enterprises are just passively waiting for the government's monitoring and notification. In the pre listing registration and approval, the risk reports of some products lack substantive analysis, evaluation and control of potential risks; After listing, enterprises pay more attention to sales and ignore the risk monitoring and control after product listing

it is reported that the Ministry of health and the State Food and Drug Administration will soon promulgate and implement the administrative measures for the monitoring and re evaluation of adverse events of medical devices and the administrative measures for the recall of medical devices. The national food is the research and development base of new metal materials in China. The application of medical device risk management to medical devices issued by the drug administration will also be implemented from June 1st, 2009

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