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[Research on the Classification Management of Digital Therapeutics Software]
Xiao Jiang1, Chunqing Zhang1, Shankui Rong1
1National Institutes for Food and Drug Control, Beijing, 102629.
Abstract:
According to the current domestic laws and regulations of the medical devices classification management, combined with the characteristics of digital therapeutics products and the existing status of classification management of medical software products in China, and drawing on international classification management experience, this study discusses and analyzes the attribute definition and classification of digital therapeutics software products, with a view to provide reference for the classification management of digital therapeutics software products.
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