What SaMD in China has clinical exemption?
According to the Medical Device Classification Catalog, SaMD is a software that has one or more medical purposes to accomplish the intended use without medical device hardware, and operates on
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2024 China NMPA Bluebook is here:
According to the Medical Device Classification Catalog, SaMD is a software that has one or more medical purposes to accomplish the intended use without medical device hardware, and operates on
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