1.）《醫療器械經(jīng)營(yíng)許可證申請表》

2）《營(yíng)業(yè)執照正副本原件)(復印件)

3）法定代表人、企業(yè)負責人、質(zhì)量負責人的身份證明、學(xué)歷或者職稱(chēng)證明復印件；

4.）組織機構與部門(mén)設置說(shuō)明

5）經(jīng)營(yíng)場(chǎng)所、庫房地址的地理位置圖、平面圖、房屋產(chǎn)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(jīng)營(yíng)設施、設備目錄

7）經(jīng)營(yíng)質(zhì)量管理制度、工作程序等文件目錄;

8）辦理醫療器械經(jīng)營(yíng)許可證企業(yè)已安裝的計算機信息管理系統基本情況介紹和功能說(shuō)明,

9）凡申請企業(yè)申報材料時(shí),辦理人員不是法定代表人或企業(yè)負責人本人,企業(yè)應當

Device Business License 2) Original copy of the business License) (photocopy) 3) Copy of the identity certificate, educational background or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of ; 4.) Description of organization structure and department setting 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