Objecthve:To construct a quantitative ethical evaluation index system for the clinical approval of medical technology in China.Methods:Exploratory factor analysis (EFA) and first-order confirmatory factor analysis (CFA) based on a structure equation model (SEM),higher-order CFA and normalisation were used to establish an ethical evaluation index system for the clinical approval of medical technology.Data were processed in SPSS 13.0 and Lisre 15.3.Results:There were 52 third class indices,15 second class indices,and 3 first class indices in this ethical evaluation index system.The weight of each index was calculated by normalisation.Conclusion:This study developed a three-level ethical evaluation index system,comprising 70 indices,for the clinical approval of medical technology.