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[Technical Exploration of Classification Management for Medical AI Large Models]
Xiao Jiang1, Di Liu2, Chenxi Wang1
1Institute of Medical Device Standardization Administration, National Institutes for Food and Drug Control, Beijing, 102629.
Abstract:
The development and application of medical artificial intelligence (AI) large models in the medical field have brought opportunities and challenges to regulation. By reviewing the application and technical characteristics of AI large models in the medical field, starting from the perspective of medical device classification management, drawing on foreign regulatory experience, and based on China's regulatory reality, the technical characteristics of medical AI large models are analyzed. Provide suggestions for defining attributes and categorizing AI large models, and offer reference for their technical classification management.