本报告结合产品、企业两个角度，开展人工智能独立软件创新医疗器械申请、审查通过和注册情况的统计分析，以及第三类人工智能独立软件产品注册情况的统计分析，选取肺结节CT图像辅助检测软件、糖尿病视网膜病变眼底图像辅助诊断软件、病理图像人工智能分析软件三种典型产品概述相应审评关注点，明确今后人工智能医疗器械监管科学研究方向和监管工作重点。
Combining the two perspectives of products and manufactures，the data of the application，qualification and registration of innovative medical devices of artificial intelligence Software as a Medical Device（SaMD） products are statistical analysed，as well as the registration data of Class III artificial intelligence SaMD products. Three typical products，including CT image-assisted detection software for pulmonary nodules，fundus image-assisted diagnosis software for diabetic retinopathy，and artificial intelligence analysis software for pathological images，were selected to summarize the corresponding premarket review concerns，and clarify the scientific research direction and regulatory focus of artificial intelligence medical device regulation in the future.
