Objective：Study the issue of new regulations and the overall development of medical device clinical trials in China. Methods：Summarize and organize the administrative regulations and relevant normative documents related to medical device clinical trials issued by the State Food and Drug Administration of China in 2017，and analyze the influence of these new laws and regulations on medical device clinical trials in China. Results：In 2017，it was a year that new regulations about medical device clinical trialswere rapidly updated. In this year，the State Food and Drug Administration issued many new regulations and guidelines covering a wide range of areas，such as the revision of regulations，accelerating approval，encouraging innovation of medical devices，improving registration methods，strengthening clinical trial management，improving technical capabilities and many other aspects. Conclusion：With the implementation of new laws and regulations，the overall level of medical device clinical trials in China will be greatly improved，which promotes the rapid development of medical devices industry in China.