人工智能医疗器械典型产品注册情况分析

Analysis of Registration Data for a Typical Artificial Intelligence Medical Device

第三类深度学习独立软件是人工智能医疗器械的典型产品,统计分析其注册数据有助于了解人工智能医疗器械产业发展态势并完善监管要求。本文统计分析了2020~2023年我国第三类深度学习独立软件的注册数据,结果表明我国人工智能医疗器械产业进入稳定发展新阶段,呈现良好发展态势,具有广阔发展空间。我国人工智能医疗器械监管工作已取得阶段性成果,基于产业发展态势,后续需要加强重点产品监管科学研究、头部企业调研、新入企业培训、信息化建设等工作。

The Class III deep learning SaMD is a typical product of artificial intelligence medical devices,and statistical analysis of its registration data helps to understand the development trend of the artificial intelligence medical device industry and improve regulatory requirements.This paper statistically analyzes registration data for the Class III deep learning SaMD in China from 2020 to 2023.The results indicate that China's artificial intelligence medical device industry has entered a new stage of stable development,showing a positive trend with broad development prospects.Phased achievements have been made in China's artificial intelligence medical device supervision,and follow-up works should focus on strengthening scientific research on key products,conducting surveys of leading enterprise,providing training for new enterprise,and enhancing information construction based on the industrial development trend.