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Comparison of innovative medical devices between China and the United States
Xu Song1,2,3, Bo Yuan2,3, Kai Zhang1,2,3
1Institute of Regulatory Science for Medical Devices, Sichuan University, Chengdu 610064, China.
Abstract:
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.
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