Part 8 Takeaways


This session of the webinar introduces takeaways. The speaker labeled in following points: clinical evaluation shall be conducted through the entire life cycle of the device; from clinical trial exemption to clinical evaluation exemption; equivalence device+comparable device; 16 comparison: comparison in clinical, technical, and biological aspects; clinical trail decision-making process flow chart;qualification of clinical evaluator must be provided;issues to be clarified: periodical updating frequency; choice of comparison device and etc.