If you write a description on the products exempted from the clinical catalogue, and then attach a comparison table between the declared products and the listed products, if you don't enter the clinical catalogue, you can compare the products of the same variety. The key point of this method is that the strength of the material is not lower than the strength of the clinical trial, that is, you should provide a clinical trial report comparing the products of the same variety. If there is nothing, you can conduct clinical trials according to the regulations and finally write a clinical trial report.
How to write and refer to the technical guidelines for clinical evaluation of medical devices?
Product registration application materials are the secret of every company, and it is unlikely to give you a template to see. If you have any specific questions in the compilation process, you can ask them or leave them on QQ for discussion.