辦理二類(lèi)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)執照正副本以及公章；

4.庫房地址材料；

三類(lèi)醫療器械經(jīng)營(yíng)許可證辦理流程

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

二、提交完畢后需要準備以下資料去現場(chǎng)提交材料

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

 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