IVD Reagent
For the filing of class I IVD reagents, clinical trial is not required. For the registration of class II and III IVD reagents, clinical trials should be conducted.
The list of class II and III IVD reagents that are exempted form clinical trial is not yet available.
For more information about clinical trials, please see Clinical Trials.
The list of class II and III IVD reagents that are exempted form clinical trial is not yet available.
For more information about clinical trials, please see Clinical Trials.