From October 1, 2014 to June 30, 2025, China and the United States (U.S.) have implemented varying degrees of reform in the review and approval systems for innovative medical devices (IMDs), establishing and developing special review pathways for such devices. These reforms aim to further encourage the development of IMDs and accelerate the provision of safe and effective medical solutions to patients with unmet clinical needs. In this perspective, we analyze data on IMDs granted IMD Designations and that received marketing authorizations, and examine their development trends.
Song et al. (Thu,) studied this question.