The marketing authorization holder（MAH）is a major reform system about drug and medical devices in China. Under the current laws and regulations，the medical devices registrant system in Shanghai is equated with MAH. The system innovation can effectively promote the rational allocation of industry resources and improve the technical research and development level of medical instrument products by relieving the binding relationship between medical devices registration and production. In the future，it will be established in “Regulations for the Supervision and Administration of Medical Devices” and become the basic legal system for the medical device industry.