For medical device products that are exempt from clinical evaluation, the relevant information submitted should be classified as "other information" in the non clinical data.The specific requirements are as follows: For Class II and Class III medical devices that are exempt from clinical e

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 typ

When other data sources (such as non clinical trials, existing clinical data, etc.) cannot demonstrate the product's compliance with the basic principles of safety and performance (including safety, clinical performance and/or effectiveness, as well as the acceptability of benefit/risk ratios),