Registration application is an important part of the medical device market access.The electronic submission of registration application is an important way to reduce the burden of registration applicants, improve the quality of registration and efficiency of the review and approval. Based on the electronic submission practice of USFDA registration application, this study reviews the development of USFDA electronic submission of medical devices, compares the differences between the traditional electronic submission template (eCopy) and the latest electronic submission template (eSTAR), and focuses on the structure and functional characteristics of eSTAR. Combined with the trend of electronic filing of medical device registration applications in China, this study reveals the implications of USFDA electronic submission of medical device registration application for China, and extends suggestions to provide references for the high-quality development of electronic submission of medical device registration application in China and the service for Chinese enterprises to expand the worldwide market, including strengthening the top-level design of the system, improving data governance capabilities, using artificial intelligence to empower, increasing review resources embedded and enhancing communication with applicants.