辦理醫(yī)療資質(zhì)許可證，您需要具有相關(guān)的人員，庫房地址以及產(chǎn)品編號(hào)，我司均可以為您提供。

辦理二類備案您需要提供：

1.法人身份信息；

2.質(zhì)量員身份信息；

3.公司營(yíng)業(yè)執(zhí)照正副本以及公章；

4.庫房地址材料；

三類醫(yī)療器械經(jīng)營(yíng)許可證辦理流程

一、要網(wǎng)登，申請(qǐng)醫(yī)療器械經(jīng)營(yíng)許可證填寫公司相關(guān)資料并提交。

二、提交完畢后需要準(zhǔn)備以下資料去現(xiàn)場(chǎng)提交材料

1.）《醫(yī)療器械經(jīng)營(yíng)許可證申請(qǐng)表》

2）《營(yíng)業(yè)執(zhí)照正副本原件)(復(fù)印件)

3）法定代表人、企業(yè)負(fù)責(zé)人、質(zhì)量負(fù)責(zé)人的身份證明、學(xué)歷或者職稱證明復(fù)印件；

4.）組織機(jī)構(gòu)與部門設(shè)置說明

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(quán)證明文件或者由房屋租賃所出具的房屋租賃憑證復(fù)印件,屬倉儲(chǔ)委托區(qū)療器械第三方物流的,提供委托合同(復(fù)印件1份,).

6）經(jīng)營(yíng)設(shè)施、設(shè)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(yī)療器械經(jīng)營(yíng)許可證企業(yè)已安裝的計(jì)算機(jī)信息管理系統(tǒng)基本情況介紹和功能說明,

9）凡申請(qǐng)企業(yè)申報(bào)材料時(shí),辦理人員不是法定代表人或企業(yè)負(fù)責(zé)人本人,企業(yè)應(yīng)當(dāng)提交《授權(quán)委托書》 (原件1份)

repare the following materials to submit the materials on site 1.) Application Form for Medical 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 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 i