From the participation of member bodies in different technical committees of ISO/IEC, development on overlapping areas of medical devices, standardization system and adaption between international standards and national regulations, this article is to analyze and conclude the development situation on international standardization of TCM medical devices and put forward the following suggestions: strengthening on talents education and training, encouraging participation from TCM medical devices enterprises, focusing on market demands, taking the adaption between the international standards and national regulations into consideration and strengthening the communication and cooperation between different organizations to improve the standard system of TCM medical devices.