Analysis of the Market Pattern and Trends of the Domestic Artificial Intelligence Medical Device Industry in 2025
01 Policy Support
In recent years, China has attached great importance to the development of AI. The Central Committee of the Communist Party of China, the State Council, and departments such as the Ministry of Science and Technology and the Ministry of Industry and Information Technology have successively introduced a series of policies aiming to guide, support, and regulate the healthy development of the AI industry. The content covers many aspects, including the development roadmap of AI technology, ethical norms, and the construction of a standard system.
02 Product Registration
- Registration status over the years
According to the statistics of Joinchain, as of the end of May 2025, the number of registered AI SaMD products in China reached 135, and the number of registered medical device products related to AI SaMD (including ultrasound, DR, digestive endoscopy, etc.) reached 2,100.
- Product registration type
As of May 2025, the registration of AI SaMD products in China was mainly distributed in departments such as respiratory medicine, neurology, orthopedics, and cardiovascular medicine. CT imaging accounts for the highest proportion, and emerging fields such as pathology and human movement are emerging.
Based on the functional division of AI SaMD, it can primarily be categorized into types such as auxiliary detection, auxiliary evaluation, auxiliary triage, and auxiliary analysis.As of the end of May 2025, there has been a significant number of registrations for the three categories of auxiliary detection, auxiliary evaluation, and auxiliary triage in China, with the combined proportion of these three categories accounting for nearly 65%.
03 Enterprise Layout
As of the end of May 2025, nearly 60 domestic enterprises have been granted AI SaMD registration certificates. Among them, brands such as Yukun Network Technology, Infervision, United Imaging Intelligence, and Deepwise have obtained a significant number of certificates, accounting for nearly 46% of the total.
From the application scenarios of products under the top 5 brands in terms of the number of AI SaMD certifications, most AI SaMD software focuses on medical fields such as cerebrovascular, pulmonary, cardiovascular, and skeletal systems.
04 Market Pattern and Trend Prediction
Since 2020, China’s SaMD/AI medical device industry has experienced rapid development, with the market size growing from less than 100 million yuan to nearly 4 billion yuan. It is estimated that it will reach 18 billion yuan by 2030. There are numerous participants in China’s SaMD/AI medical device industry, with Infervision and Shukun Technology accounting for more than half of the market share.
Meanwhile, since 2020, the market size of SiMD/AI-related medical devices in China has grown even more rapidly. It is estimated that by 2030, the proportion of devices with SiMD/AI-assisted diagnostic functions will reach over 90%, and the market size will exceed 100 billion yuan. The main players in China’s SiMD/AI-related medical device market are companies such as GPS Lianying, with a CR4 (Concentration Ratio of the Top Four Enterprises) of over 60%.
Currently, the domestic AI medical device market still holds poten
China is encouraging China end uses for more domestic products in latest years. Thus, more and more overseas manufacturers are planning localization in China. BradyKnows localization team has extensive experiences in facility establishment, audit, supplier evaluation, manufacturing, registration, and marketing in China. Pls feel free to let us know any questions on China entry via info@bradyknowsmedical.com
Translated & edited：Bradyknown
Source： Joinchain
