What is the content of the administrative measures for medical device recall (for Trial Implementation)?

Medical device recall refers to the behavior of medical device manufacturers to eliminate defects by warning, inspection, repair, re labeling, modifying and improving instructions, software upgrading, replacement, recovery, destruction and other means according to the prescribed procedures for a certain category, model or batch of products with defects that have been sold on the market. In order to strengthen the supervision and management of medical devices and ensure human health and life safety, the State Food and drug administration has formulated and issued the administrative measures for recall of medical devices (Trial) (Order No. 29 of the State Food and Drug Administration). Medical device manufacturers are the main body to control and eliminate product defects, and should be responsible for the safety of their products. Medical device manufacturers shall establish and improve the medical device recall system in accordance with the provisions of these measures, collect relevant information on the safety of medical devices, investigate and evaluate the medical devices that may have defects, and timely recall the defective medical devices.

Post time: Dec-10-2021