Abstract: In recent years, the medical device industry has developed rapidly, with new technologies and products constantly emerging. Consequently, the demand for pre-registration communication services has increased. Through literature and policy analysis, this paper systematically reviews the institutional policies and implementation pathways of the coordinated mechanism for research and evaluation in China and the United States, and compares and analyzes the differences between the two systems. The paper proposes insights for reforming China's medical device review and approval policies, thereby promoting industrial innovation and high-quality development.