What are the requirements of medical device recall?

Medical device manufacturers shall establish and improve the medical device recall system in accordance with the administrative measures for medical device recall (Trial Implementation) issued by the Ministry of health and implemented on July 1, 2011 (Order No. 82 of the Ministry of Health), collect relevant information on the safety of medical devices, and investigate and evaluate the medical devices that may have defects, Recall defective medical devices in time. The medical device business enterprises and users shall assist the medical device manufacturers to fulfill their recall obligations, timely convey and feed back the recall information of medical devices in accordance with the requirements of the recall plan, and control and recover the defective medical devices. If a medical device trading enterprise or user discovers any defect in the medical device it operates or uses, it shall immediately suspend the sale or use of the medical device, promptly notify the medical device manufacturer or supplier, and report to the local drug regulatory department of the province, autonomous region or municipality directly under the central government; If the user is a medical institution, it shall also report to the health administrative department of the province, autonomous region or municipality directly under the central government where it is located.