Registered Production And Certification
The medical device registrant system refers to a management model that separates the medical device marketing license from the medical device production license. Under this system, medical device registrants can entrust products to different manufacturers for production or research and development, and the registrants are responsible for the safety, efficacy and quality of the products.
The regulations on the entrusted production mode in the medical device registrant system have promoted the refined division of labor in the industry. This system allows registrants to entrust production at multiple points, so that enterprises no longer have to build their own factories. This will enable those who are good at R&D to focus only on R&D, and those who are good at production only need to focus on production, which greatly improves the utilization rate of industry resources and is of great help to corporate innovation and industrial upgrading. In addition, the entrusted production model will promote a more refined division of labor and cooperation between medical device R&D institutions and manufacturing enterprises in some sub-fields of medical devices, and optimize the allocation of industry resources.
The "unbinding" of medical device registration and production has lowered the barriers to entry in the medical device industry. It is more convenient for capital, entrepreneurs and social resources to enter the medical device industry under the medical device registrant system. This not only expands the market size of the medical device industry, but also improves the utilization of resources.
Xihe Medical actively responds to the call of the state and plans to undertake the commissioned production of medical devices as a trustee and become a third-party service enterprise for medical devices.