What are the registration requirements for a Class III medical device company?
Three types of medical device company registration requirements are: 1, with the scope of business and business scale of the personnel; 2, with the scope of business and business scale of the business, storage place; 3, the establishment and implementation of the relevant laws and regulations in line with the requirements of the actual enterprise quality management system, regulations or quality management system documents. Class III medical device company required materials are: 1, medical device business license application form; 2, business license and organization code certificate copy; 3, legal representative, the person in charge of the enterprise, the person in charge of quality of the identity, education or title certificate copy; 4, organizational structure and departmental setup description; 5, computer information management system basic information and functional description; 6, business facilities, equipment Directory; 7, the operator's authorization certificate; 8, data authenticity guarantee statement.