Comparison of innovative medical devices between China and the United States

Key Points

Innovative medical devices have shown significant growth in both the U.S. and China, addressing unmet clinical needs.
From 2014 to 2025, both countries reformed their review pathways to expedite the availability of innovative medical solutions.
Data analysis indicates that marketing authorizations for these devices increased as regulatory reforms took place.
These reforms may enable faster access to safe and effective medical devices, benefiting patients and healthcare providers.

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.

Comparison of innovative medical devices between China and the United States

Key Points

Abstract

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