Are clinical evaluations required for products already approved or is this requirement only for new products? | BradyKnows

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I believe the clinical evaluation is required for all products including products that have been approved in China.

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Previous: The regulation (annex I) mentions that ‘During the design development phase, clinical evaluation is required to determine the clinical data needed for premarket product evaluation, to determine whether a clinical trial is needed and the clinical endpoints that need to be observed’ Is that not very similar to the EU Clinical Evaluation Plan? How should it be documented?

Next: We’ve been told to take a “wait & see” approach with regards to the new NMPA guidelines to bypass full clinical investigations for a new ventilator. Are you also in line with a more “relaxed” stance for CER coming from the latest NMPA guidelines?