1. Complaints or clues from other channels indicate that there may be quality and safety risks;
2 inspection found that there are quality and safety risks;
3. The monitoring of medical device adverse events suggests that there may be quality and safety risks;
4. The authenticity of the application materials is in doubt;
5 suspected of serious violation of the requirements of quality management standards;
6. The enterprise has a serious record of dishonesty;
7. Other circumstances that require flight inspection.