What conditions need to be met to handle the Shanghai medical device license

What conditions need to be met to apply for a medical device license in Shanghai, with the impact of the epidemic, the medical device industry has also developed, for more and more companies in the medical device industry, then for the Shanghai medical device license need to meet what conditions? Next we will take a brief pick up. For Shanghai medical device license need to meet what conditions 1, "device business enterprise license application form", "device business enterprise license"; 2, administrative departments issued by the "pre-approval of enterprise name notice" or "business license"; 3, application report; 4, business premises, warehouse premises supporting documents, including property certificates or lease agreements and copies of the lessor's real estate certificates; 5 , business premises, warehouse layout plan; 6, the proposed approach to determine the person in charge, the person in charge of the enterprise, the quality manager's, a copy of the certificate of academic qualifications or title certificate and biographical information; 7, a list of technical staff and a copy of the academic qualifications, title certificate; 8, business quality management specification document directory; 9, the enterprise has been installed in the product purchasing, sales and storage of the information management system, print the first page of the information management system; 10, Warehousing facilities and equipment directory; 11, quality management personnel on duty self-assurance statement and self-assurance statement of the authenticity of the application materials, including the directory of application materials and the enterprise on the material to make any false commitment to bear legal responsibility; 12, where the application for the enterprise to declare the material for the personnel is not the legal representative or person in charge of the person himself, the enterprise should be submitted to the "letter of authorization"; 13, the application for the "device business enterprise License" confirmation of the application for a device business enterprise license material requirements: business enterprises to submit the "device business enterprise license application form" should be signed by the legal representative or stamped with the official seal of the enterprise.