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), clinical trials need to be conducted.
If clinical evaluation is conducted through the clinical trial pathway, the clinical trial protocol, written opinion from the ethics committee of the clinical trial institution agreeing to conduct the clinical trial, clinical trial report, sample of informed consent form, and the clinical trial database (original database, analysis database, explanatory documents, and program code) should be submitted.