With the adjustment of the China economic structure，medical device has been an important policy support and development industry. The strategic requirements of several major medical instruments have been introduced from the national level. The departments at all levels have carried out the revision of the large-scale medical instrument law regulation. The new regulatory system for medical device supervision will have a profound impact on the healthy development of the whole industry. From the perspective of medical equipment production enterprises，this paper studies the major changes in the new regulatory system of medical device supervision and regulation，and puts forward some suggestions on how to adapt to the new regulatory requirements and establish the regulatory system that meets the requirements of the medical device manufactures.