JMIR Publications

ABSTRACT

Background:

Artificial intelligence (AI) has emerged as a transformative force in modern healthcare.

Objective:

This study aims to analyze the approval of AI-based medical devices (AIMDs) in China.

Methods:

We conducted a search of the Drugdataexpy database to identify AIMDs approved through 30 June 2025, using AI related keywords in the structural composition and intended use fields. After manual verification and exclusion of non-AIMDs, we collected key device characteristics such as name, manufacturer, and approval date. Statistical analysis was performed using descriptive statistics and Pearson's χ² tests to assess the associations between risk classification and categorical variables.

Results:

We identified 154 AIMDs and observed rapid growth, with approvals rising from 9 in 202 to 45 in 2024. Radiology applications dominated the landscape (68.83%), particularly CT-based solutions for pulmonary nodules and cardiovascular conditions. Most devices were classified as Class III (79.22%) and utilized deep learning architectures (92.9%). Market concentration was evident, with 77.92% of AIMDs originating from four cities (Beijing, Shanghai, Shenzhen, Hangzhou) and the top four manufacturers accounting for 36.4% of approvals.

Conclusions:

China's AIMD landscape exhibits distinct characteristics shaped by domestic regulatory frameworks and disease priorities. These findings offer valuable insights for optimizing regulatory strategies and guiding future development in this rapidly evolving field.