Imported Medical Device
For the filing of class I MDs, clinical trial is not required. For the registration of class II and III MDs, clinical trials should be conducted.
For some products clinical trial is exempted, as listed in:
CFDA circular about the directory of class II MDs exempted from clinical trial (No. 12, 2014)
CFDA circular about registration approving work standard of domestic class III MDs and imported MDs.
For more information about clinical trials, please see Clinical Trials.