The production of medical aluminum tubes must have a medical device manufacturer's license, medical device business license, quasi-nominal medical device registration certificate. These certificates are audited and issued by the local Drug Administration. Starting a medical device manufacturer should be in line with the national medical device industry development plan and industrial policy.
Engaged in the production of medical devices, should have the following conditions, 1, with the production of medical devices compatible with the production site, environmental conditions, production equipment and professional and technical personnel. 2, there is the production of medical devices for the quality of the institution or a full-time inspectors and inspection equipment. 3, there is to ensure that the quality of the medical device management system. 4, and the production of medical devices compatible with the after-sales service capacity. 5, product development and development of medical devices. After-sales service capabilities. 5, product development, production process documentation requirements.