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China will implement the medical device recall system
Release time: 2010-09-16 & nbsp & nbsp & nbsp Source:
China will establish a recall system for medical stake online sports bettingStake Sports Bettingdevice products,Production companies find that medical devices do not meet relevant requirements,It should be recalled immediately。
The "Regulations on the Supervision and Administration of Medical Device (Draft for Opinions)" released by the Legal Affairs Office of the State Council on the 6th (hereinafter referred to as soliciting opinions),Medical device manufacturers found that the medical equipment produced by it does not meet the national standard of medical device、Technical requirements for medical device products,Should stop production immediately,Recall medical equipment that has been listed on sale,Notification of relevant production and operators and consumers,Record the recall and notification situation,Post related information。
Soliciting opinion draft also stipulates,Medical device manufacturers shall stake sports betting appStake Sports Bettingremedy the recalled medical equipment、Destruction and other measures,Report the recall and treatment of medical equipment to the food and drug supervision and management department。Medical equipment production and operation enterprises have not implemented recalls or stop operations in accordance with regulations,Food and Drug Supervision and Administration Department may order it to recall or stop operation。
At the same time,Draft for soliciting opinions requires medical device production and operation enterprises and users to record in accordance with the provisions of these regulations,Make sure its production、Business、Medical devices used can be traceable;,It should be ensured that patients who can be traced back to the medical equipment。State will establish a bad event monitoring system for medical devices,Collection、stake betting appStake Sports BettingAnalysis、Evaluation、Control medical equipment bad events。
Soliciting opinion draft also stipulates,The food and drug supervision and management department of the people's government at or above the provincial level shall take corresponding control measures in a timely manner based on the evaluation results of the bad events of medical device。It should also be organized to cause emergencies、Patients with severe injuries or deaths that are severely investigated and dealt with in a timely manner,and strengthen the monitoring of related similar medical equipment products。