Part 1 Clinical Requirements


In this session of the webinar, the speaker talks about the clinical strategy for the registration of respiratory equipment and patient monitoring devices, the scenarios when clinical trials may be needed for respiratory equipment, patient monitoring devices that are exempted from clinical evaluation in China. This session also introduces the major changes to clinical evaluation under Order 739 including the clinical pathways, clinical evaluation for the entire product lifecycle, new clinical evaluation guidance, when you can submit a Clinical Evaluation Report (CER) in lieu of a Clinical Study Report (CSR). In details, the speaker talked about the clinical evaluation of medical device via equivalence, the equivalence comparison and choice of equivalent devices, the necessity of clinical trials in China, and the use of overseas clinical data to meet NMPA clinical requirements. The speaker also gives a flavor on the writing of China Clinical Evaluation Report (CER) under the new Order 739 regulation and the major difference between a China CER and a European MDR CER.