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Importing IVD Products to China

IVD that has been approved by its country of origin's regulatory entity can apply for importation into China as a clinical test. However, IVD products that are used for research (RUO agents) do not need to go through the registration process. For clinically used IVDs, importation requires am importation certificate issued by the SFDA. The imported products are classified within three classes, and different categories have different requirements with respect to clinical trials and the application process. A brief introduction on classification is shown below.



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