Application materials:
(1) A report on the application for the establishment of a medical device business enterprise, and fill in or print the Application Form for the License of a Medical Device Business Enterprise (in quadruplicate);
(2) Notice of pre-approval of enterprise name issued by the administrative department for industry and commerce;
(3) personnel information;
1. Identity cards, household registration books of the legal representative and the person in charge of the enterprise, or relevant certificates, education certificates and health certificates issued by the public security organs;
2. A copy of the ID card, education or professional and technical post certificate of the quality management personnel of the enterprise to be employed, and their resumes, employment agreements and health certificates;
3, the proposed enterprise personnel roster, and health certificate. The contents of the roster include: name, gender, age, professional and technical position/education, position/post.
(4) The organizational structure and functions of the proposed enterprise;
An enterprise should draw up an organization chart to clarify the division of labor within the enterprise and the post functions of enterprise personnel.
(five) the geographical location map, floor plan (indicating the area) of the registered address and warehouse address of the proposed enterprise, and a copy of the property right certificate (or lease agreement).
(six) the product quality management system documents and the catalogue of storage facilities and equipment of the enterprise to be established;
(seven) the business category of the enterprise to be established;
The catalogue includes the following contents: product name, manufacturer, specification, registration number, and description of storage conditions and requirements of corresponding products.