Objective To guide medical device registration applicants to carry out product stability research activities combined with risk management in the whole life cycle of medical devices by reviewing the guiding documents and standards related to medical device stability research in China and the United States, and to provide ideas for technical reviewers when reviewing related content. Methods The contents of stability research were discussed from shelf life, use stability and transportation stability, and the design ideas of verification scheme were provided for each aspect. From the perspective of review, suggestions were provided on how to submit a complete set of research data which was convenient for reviewers to study and judge. Results With the development of science and technology, the complexity of medical devices is increasing, so product stability research is also a continuous development process, which requires enterprises and reviewers to use scientific methods for research and judgment.