1, the production, operation and use of medical devices do not meet the mandatory standards or do not meet the technical requirements of the products by the registration or filing;
2, the medical device manufacturer is not in accordance with the technical requirements of the products by the registration or filing Registered or filed product technical requirements for the organization of production, or not in accordance with the provisions of this regulation to establish a quality management system and maintain effective operation;
3, the operation and use of no qualification documents, expired, expired, out of medical devices, or the use of medical devices are not registered in accordance with the law;
4, the food and drug supervision and management department ordered in accordance with the provisions of this regulation to implement Recall or stop operating, but still refused to recall or stop operating medical devices;
5, commissioned by the enterprise does not have the conditions specified in these regulations to produce medical devices, or not the production of the entrusted party to manage the behavior.