Business agency news on 11 June , the Ministry of Health announced on 10, "Medical Device Recall (Trial)", and will be came into effect on July 1, 2011.
Management approach in the main responsibilities of the recall, scope, time,classification, legal responsibilities clearly defined. Medical device manufacturersare considered the main recall. Recall will be divided into two types of active recalland ordered recall.
Under this management approach, medical equipment in normal use may endangerthe existence of human health and safety of unreasonable risk, warning should betaken according to prescribed procedures, inspection, repair, re-label, modify and improve the specification, software upgrades, replacement, recovery, destruction, etc. to eliminate defects. Drug administration after review and evaluation, that therecall is not complete, elimination of defects is not effective, will require manufacturers to recall again.
According to the severity of defects in medical devices, medical equipment recall will be divided into three levels, respectively, in 1, 3 and 7 days, by medical device manufacturers will be informed of the decision to recall the medical equipment enterprises, and building user or inform the user.
Management practices required that medical device manufacturers who not take the initiative to recall defective medical devices which should be ordered to recall, recall of medical devices should impose a value of three times the amount of the fine; causing serious consequences, the original issuing authority shall revoke the certificate of medical device product registration, or revoke"Medical device Manufacturing Enterprise License." (Correspondent Hu Hao, Zhou Tingyu)
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