Do medical equipment agents need to have what conditions

Engaged in the production of medical devices, should have the following conditions: (a) with the production of medical devices compatible with the production site, environmental conditions, production equipment and professional and technical personnel; (b) the production of medical devices to carry out quality inspection of the organization or full-time inspectors and inspection equipment; (c) have to ensure that the quality of medical devices management system; (d) with the production of medical devices compatible with the after-sales service capabilities; (e) meet the requirements of the product development and production process documentation. (D) with the production of medical devices compatible with the after-sales service capacity; (E) in line with the product development, production process documentation requirements.　The opening of the second class, the third class of medical device manufacturers, should be located in the provinces, autonomous regions and municipalities directly under the Central Food and Drug Administration to apply for production permits, and submit the following information: (a) a copy of business license, organization code certificate; (b) the applicant company holds a copy of the registration certificate of the production of medical devices and product technical requirements; (c) legal representative, the person in charge of the enterprise copy of the identity certificate (IX) process flow diagram; (X) by the person authorized to prove; (XI) other supporting information.