RESUMEN
OBJECTIVE: 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 l5.3. 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.