Abstract: OBJECTIVE To establish a scientific and objective competency evaluation index system for "4-Product & 1-Device" (referring to food, drug, cosmetics, health food and medical devices in this paper) inspectors. METHODS The competency elements were defined based on four-dimensional competency theory by means of literature analysis, job analysis and expert interview. Then thirteen "4-Product & 1-Device" experts were consulted by using Delphi technique. RESULTS The "4-Product & 1-Device" competency evaluation index system was comprised of 4 first-class indicators and 14 second-class indicators. The results showed that the expert consultation had high level of enthusiasm, coordination and authority. CONCLUSION The "4-Product & 1-Device" competency evaluation index system is comprehensive and integrated, can provide a scientific reference for "4-Product & 1-Device" inspectors practice management.