Legal analysis: 1, "Medical Device License Application Form" (1 original);
2, "Business License" (copy);
3, quality management personnel's work resume (1 original);
4, legal representative, responsible person for the enterprise, the person in charge of quality of the identity of the person in charge of the certificate of qualifications or professional title (1 copy);
5, for medical device license companies have installed computer information management system basic information and functional description , print information management system home page (1 original);
6, list of professional and technical personnel (1 original) and professional and technical personnel identity card, proof of education, professional title certificate (copy of a copy of each);
7, operating Facilities, equipment catalog;
8, organizational structure and departmental setup description;
Legal basis: "Chinese People's Republic of China *** and the State Regulations on the Administration of the Registration of Enterprise Legal Person" Article 3 Apply for the registration of the enterprise legal person, by the competent authority for the registration of the enterprise legal person examination and approval of the registration of the enterprise legal person, to receive the "Enterprise Legal Person Business License", to obtain the qualification of a legal person, and its lawful rights and interests by the state law protection. Required by law for the registration of enterprise legal person, without the approval of the competent organ for the registration of enterprise legal person registration, shall not engage in business activities.