ABSTRACT
Objective To study the impacts of changes in medical device policies and regulations on the industry when the state department decides to revise Medical Devices Supervisory Management Act.Methods The impacts were discussed from the aspects of the scale of enterprise, number of product filing and registration and industry development environment. Results The changes of the policies and regulations had no great effect on the scale of enterprise while standardized the enterprise filing and registration and facilitated its development.Conclusion Management system based on medical device product lifecycle has been initially formed.Medical equipment enterprises should actively grasp the new regulatory changes and improve the quality compliance management by innovating product and technology, in order to make good use of the dividends brought about by changes in policies.