Medical device has been widely used for disease prevention，diagnosis，treatment and rehabilitation，and has become an important means of modern medicine. And recently，the public demand higher technological medical device with the development of medical device industry，and pose higher requirements on the safety and effectiveness of medical devices，and the standard is one of the most basic means to guarantee the safety and effectiveness of medical device products，so it is of great significance to strengthen the medical device standards management. This article is to introduce the existing state of the medical device standard management，analyze the existing problems and give the corresponding recommendations.