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nmpa
26
Feb

Clinical Exemptions for SaMD in China

February 26, 2020
In the China National Medical Products Administration (NMPA) Classification Catalog, SaMD can be Class II and III; it cannot be Class I.  This means that not all SaMD will require clinical trials and may fit into clinical exemptions for SaMD in China.  According to Medical Device Clinical Trial Exemption Catalog issued on September 30, 2018, seven...
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