Under the current medical device supervision system，medical device manufacturers need to have a perfect quality management system in advance when applying for product listing. The system of medical device registrant allows the separation of technology holding and production resources，which is expected to change this situation and the development mode of medical device industry. This paper analyzes the policy opportunities and challenges faced by the start-ups of Medical Devices，analyzes the advantages of CDMO mode，and discusses the specific practice of the third-party institutions under this system.