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Whether Media For IVF Products Can Use CER As Clinical Pathway For China Registration?

2021-10-18

Some liquid products for in vitro assisted reproduction have entered the Catalogue of Medical Devices Exempted from Clinical Trials. For the products that are not in the catalogue, it is recommended to select appropriate clinical evaluation paths, including clinical trials and CER pathway, based on the actual characteristics of the declared products and the available supporting dossiers.

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