Comparison of innovative medical devices between China and the United States

Regenerative Biomaterials 2026 Open access

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Authors: Xu Song, Bo Yuan, Kai Zhang, Chunying Chen, Yuliang Zhao, Antonios G. Mikos, Xingdong Zhang
DOI: 10.1093/rb/rbag008
Cited by: 0
References: 2

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.

Fields of Study & Subjects

Healthcare Regulation Biomedical Ethics and Regulation Pharmaceutical Economics and Policy

Publication details

Journal / source
Regenerative Biomaterials
Volume
13
Pages
rbag008–rbag008
Publication date
1 January 2026
Language
EN