Objective Schematic design is the most important part of proficiency testing program.The feasible design can ensure proficiency testing program to achieve the desired effect.In order to regulate and guide the design of the program,we analyze the various elements of proficiency testing program design.Methods Taking into account of the medical device proficiency testing program during 2006 to 2015 in National Institutes for Food and Drug Control,we described and analyzed the important factors of schematic design ，including team composition and qualification,measured value or characteristic information,stability test and homogeneity test.Results Feasible guidance of the test and evaluation methods were provided,and the standardization of the design was also included.Conclusions The schematic design has important practical significance for the testing program.