An ethical evaluation index system for clinical approval of medical technology in China: A structural equation model study.

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.