The State Food and Drug Administration issued the announcement of Shanghai food and Drug Administration on pilot work of medical device registrant system (No. 1 of 2018). In accordance with the spirit of the central reform, Shanghai food and drug administration has formulated the implementation plan for pilot work of medical device registration system in China (Shanghai) pilot free trade zone (hereinafter referred to as the program), which was approved by the State Food and Drug Administration on January 5. It is agreed in the reply that if the relevant contents in the plan are inconsistent with the current regulations and normative documents, the plan shall be implemented. This reform marks that the license holder and producer of medical devices can be separated in the future, which will lower the threshold of enterprises and be conducive to innovation and development.