Medical network on February 13 - the national food and drug supervision and administration bureau has issued the measures for the management of medical device recall, clear to strengthen risk control listed after defects in medical devices, eliminate equipment safe hidden trouble, the implementation of enterprise recall of main body responsibility, protect public safety.
According to the way, is the medical device manufacturing enterprise in the production of medical equipment quality and safety is responsible for the main body. Shall, in accordance with the regulations, establish and perfect the system of medical device recall management, medical equipment safety related information collection, to investigate the possible defects products, assessment, defect product recall in a timely manner.
According to the severity of the medical equipment defects, can recall three levels, including the recall is suitable for the use of the medical equipment may or has caused serious health hazard. Recall decision method to clear, medical device manufacturing enterprise, level of recall should be within 1 days notice to the relevant business, use the unit or inform the user.
Medical equipment management enterprise, using unit shall actively assist the medical device manufacturing enterprise for defective product investigation, evaluation, actively cooperate with production enterprises to perform the duty of recall according to the recall plan timely convey, medical device recall information feedback, control and recovery of the defective product.
Drug safety agency said, in practice, give priority to with enterprise is voluntarily recalling, government departments shall be ordered to recall is complementary. The provisions of article 24 of the way, the food and drug supervision and administration department after survey assessment, think of medical device production enterprise shall recall defective medical devices without active recall, medical device manufacturing enterprise shall be ordered to recall of medical equipment. |
