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With the Internet and mobile Internet revolution, Artificial Intelligence ("AI") has entered into a phase of rapid development. Medical products are directly related to the health of the public, and in order to ensure that they are safe and effective, regulatory authorities have always been highly cautious when dealing with innovative technologies and products, which makes it necessary to spend a lot of time in administrative procedures before the relevant medical products are put on the market. The purpose of this article is to sort out the definition, nature and management category of AI medical software and clear the way for subsequent administrative approval. |