Part 4 When Can You Submit A CER In Lieu Of A CSR


This session of the webinar introduces when can you submit a CER in lieu of a CSR. Firstly, it talks about rule of thumb, then it defines clinical evaluation via equivalence. In the equivalence comparison section, it lists the following points which were scope of application, technical characteristics and biological characteristics. The speaker also talks about some choices of equivalent devices, the necessity of clinical trails and draw a diagram to explain the clinical trail decision-making process. Finally, it explains use of overseas clinical data, such as what should have to submit and what may also need to submit.