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(kù)房地址材料；

三類醫(yī)療器械經(jīng)營(yíng)許可證辦理流程

一、首先要網(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、提交完畢后接下來需要準(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(kù)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(cāng)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

 1. Legal person identity information; 2. Identity information of the personnel; 3. The company's business license principal, secondary copy and official seal; 4. Warehouse address materials; Procedures for handling the business license of Class III medical devices 1. First of all, to network access, apply for the medical device business license to fill in the company's relevant information and submit. 2. After the submission, the next step needs to prepare 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