The market access of medical devices is a complex system engineering with high technology, high investment and high risk. In order to shorten the R & D cycle, control the cost, reduce the risk and improve the efficiency, it is an important development trend to focus the resources on the core business such as design and development and marketing, and entrust the production of samples and products to the enterprises with production conditions. In recent years, with the gradual improvement of various mechanisms and other factors, China's medical device registrant system has risen rapidly. The system has broken through the confinement that the production enterprise is the only subject of the registration applicant. It allows medical device R & D institutions and scientific researchers to apply for the listing license of medical devices, and liberalizes the subject of entrusted production, so as to unbind the registration license and production license of medical devices.

　　From the perspective of commissioned production, the system enables the technical R & D personnel to realize the technology landing and productization from the original self built factory or seeking production partners to choose the existing production enterprises or professional CMO service platform for commissioned production, which can greatly stimulate the innovation power of the medical device industry and make the resource allocation of the medical device industry more reasonable The division of labor is more detailed, and then professional R & D enterprises and production-oriented enterprises are born to improve the input-output efficiency of technological R & D innovation. In terms of market access, compared with self built plants, CMO service platform for medical devices can shorten at least one year and reduce costs by more than 50%. Therefore, it will be an important development trend for medical device registrants to entrust CMO platform for production in the future;

　　Beijing Huaguang Taihe Medical Technology Service Co., Ltd., established in 2015, has gradually developed into a leading medical device service provider in China, including medical device clinical service, medical device entrusted production and many other services, starting from medical device quality system service, regulatory training and product registration business.

　　Based on many years of service experience and customer resource accumulation, we can effectively and quickly find and connect the entrusted production enterprises / bases. At present, there are dozens of qualified production enterprises, including active device production, passive device production (protection products, sterile products and implant products) and in vitro diagnostic reagent production. The main advantages and features of CMO service platform are: it can assist medical device registrants to apply for product registration certificate and production license, and can provide venues including registrants; The establishment, docking and operation of the quality system of both parties; Process verification and research test; Sample production and product inspection; Clinical trials; Registration and production license declaration and other whole process services, as well as supervision and inspection and follow-up extension services.