OBJECTIVE： To provide reference for reconstructing medical regulatory system in China. METHODS： Through introducing medical regulatory setting mode in Britain and USA， combining the situation and problems of medical regulatory setting in China， and the assumption was put forward for medical regulatory system construction. RESULTS & CONCLUSIONS： Adhering to the principle of legalization， independence and speciality， Britain and USA set up various types medical regulatory in each professional field led by health departments. These medical regulatory institutions are charged with drug instrument regulation， medical regulation monitoring， medical insurance monitoring， and other responsibilities. In China， medical regulatory function scatters in Food & Drug Administration， Health and Family Planning Department， Human Social Security Department， Price Department， etc.There are some problems which go against the relief of “difficulty and high cost of getting medical service”and “falsely high drug price”， such as low legalization， unclear regulatory function， poor independence and speciality. So， “super health” medical regulatory system， covering administration department， industry regulator institutions and professional technology institutions led by National Health and Family Planning Commission， should be established through grasping “super-ministries” reform opportunity and integrating medical regulatory function of Food & Drug Administration， Health and Family Planning Department， Human Social Security Department， by referring to Britain and USA experience.