(a) the production, operation and use of medical devices that do not meet the mandatory standards or the technical requirements of registered or filed products;
(2) The medical device manufacturing enterprise fails to organize production in accordance with the technical requirements of registered or filed products, or fails to establish a quality management system and maintain effective operation in accordance with the provisions of these Regulations;
(three) the operation and use of unlicensed, expired, invalid or obsolete medical devices, or the use of medical devices that are not registered according to law;
(4) The food and drug supervision and administration department has ordered it to recall or stop operating in accordance with the provisions of these Regulations, but still refuses to recall or stop operating medical devices;
(5) Entrusting an enterprise that does not meet the requirements stipulated in these Regulations to produce medical devices, or failing to manage the production behavior of the entrusted party.