Abstract: In this study, the pre-marketing regulatory requirements for typical Class II wound dressings, as well as the status of testing and post-marketing adverse event monitoring, were reviewed from the perspective of the full lifecycle of medical devices. Additionally, the regulatory requirements for wound dressings in China, the United States, and the European Union were compared. Supplementary research was also conducted on liquid and paste dressing products. This study analyzed the issues in the registration and application of typical Class II wound dressings and further provided regulatory recommendations, aiming to offer technical references for the review and approval, inspection and testing, and post-market supervision of wound dressing products.