The clinical evaluation and clinical trial data of the same type are all classified as "clinical evaluation data". Except for products that are exempt from clinical evaluation catalogs, many conventional products on the market can be clinically evaluated by comparing them with the same type of medical devices.
If clinical evaluation is conducted through the same type of clinical evaluation pathway, comparative data should be submitted between the declared product and the same type of medical device in terms of applicability, technical characteristics, and biological characteristics; Clinical data of the same type of medical devices should be collected, evaluated, and analyzed to form clinical evidence. If applicable, the differences between the declared product and the same type of medical device should be described, and sufficient scientific evidence should be submitted to prove that the two have the same safety and effectiveness.