Based on the data and policies and regulations for medical devices from the last half of 2011 to 2012,we analyzed the development trend of the medical device industry in 2012,the effect of the national"12 th Five-year plan"on the development of the medical device industry and the characteristics of the regulation over medical devices in China;and estimated the development trend in the regulatory management of medical devices in the future according to Regulations on Supervision and Administration of Medical Devices(Revised) (3 rd draft for comment)issued by Legislative Affairs Office of the State Council in September 2012. <<