1, "Medical Device Manufacturing Enterprise Start-up Application Form" original
2, a copy of the registration certificate of the proposed production of medical devices
3, a copy of the business license
4, a copy of the organization code certificate
5, a copy of the property rights of the production address and / or lease agreement
6, a copy of the floor plan of the production site (indicating the building number, floor and area) and a copy of the geographic location map
7, a copy of the environmental monitoring report (applicable to special production environments)
8, a copy of the registered technical requirements of the product
9, process flow diagrams, with the main control items and control points (the key processes and special processes of the equipment, personnel and the control of process parameters) original Process parameters control) original
10, the legal representative of the enterprise, the person in charge of the enterprise, the person in charge of production, the person in charge of quality and the person in charge of the technical identity card, academic (or title) certificates copy
11, production management, quality inspection positions of practitioners in the academic qualifications, titles list, and indicate the department of the original
12, internal auditor certificates Copy copy
13, the original self-inspection report of the quality management standard for the production of medical devices
14, the original catalog of the main production equipment and inspection equipment
15, a copy of the catalog of quality manuals and procedural documents
16, the original registration form for the production of medical devices
17, self-assurance statement of the authenticity of the application materials Original
18, the original power of attorney
19, a copy of the identity card of the person in charge
20, there are entrusted with the production of medical devices, should also be submitted at the same time to the following materials
(1), commissioned by the party's enterprise business license, copy of the organization code certificate
(2), the commissioned party entrusted with the production of medical devices for the record certificate Copy
(3), a copy of the commissioned production contract
(4), commissioned the production of medical devices to be used in the original instructions, labels and packaging marking samples
(5), the commissioning party of the commissioned party's quality management system of the original statement of recognition
(6), the commissioning party on the commissioning of the production of medical devices quality, sales and after-sales service responsibilities Original self-assurance statement