4.）組織機構與部門設置說明

5）經營場所、庫房地址的地理位置圖、平面圖、房屋產權證明文件或者由房屋租賃所出具的房屋租賃憑證復印件,屬倉儲委托區療器械第三方物流的,提供委托合同(復印件1份,).

6）經營設施、設備目錄

7）經營質量管理制度、工作程序等文件目錄;

8）辦理醫療器械經營許可證企業已安裝的計算機信息管理系統基本情況介紹和功能說明,

9）凡申請企業申報材料時,辦理人員不是法定代表人或企業負責人本人,企業應當提交《授權委托書》 (原件1份)

10）申報材料真實性的自我保證聲明,包括申請材料目錄和企業對材料作出如有虛假承擔法律責任的承諾(原件1份).

三、現場提交成功后約去現場勘察，現場需提交材料

1）崗位職責

2）工作程序

3）公司制度

4）供應商檔案

5）培訓記錄

5) The geographical location map, floor plan, house property right certificate of the business site or the copy of the house lease certificate issued by the house lease, which belongs to the third party logistics of the entrusted district medical e, provide the entrustment contract (1 copy,). 6) Catalogue of operating facilities and e 7) Catalogue of operation management system, working procedures and other documents; 8) Basic information introduction and function description of the computer information management system installed by the enterprise dealing with the medical device business license, 9) When applying for the application materials of the enterprise, the handling person is not the legal representative or the person in charge of the enterprise, the enterprise shall subm