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China Vs EU Comparison: The Chart Says Clinical Evaluation Exemption Catalog: Is The Clinical Trial Exemption Catalog Meant? Is It The Same?

2021-10-18

Under Order 680, clinical trial exemption catalog was used. However, this catalog was converted to clinical evaluation exemption catalog. The content of these two catalogs is essentially the same.

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Next: 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?