一、三類醫(yī)療器知械許可證注冊所需材料

1、企業(yè)名稱與經營范圍，注冊資本及股東出資比例，股東等身份證明;

2、醫(yī)療器械產品注冊證書、供應商營業(yè)執(zhí)照、許可證及授權書;

3、質量管理文件等;

4、2個或以上醫(yī)學專業(yè)或相關專業(yè)人員證書、身份證明與簡歷;

5、符合醫(yī)療器械經營要求的辦公場地及倉庫證明;

6、公司章程、股東會決議等;

7、財務人員身份證和上崗證;

8、其它相道關材料。

二、辦理三回類醫(yī)療器械許可證的要求：

1、場地要求：必須是辦公性質，使用面積要少達到45平方米;

2、人員要求：需要有3名相關人員(公司負責人、質量負責人、質量檢查人員)的備案并且持有證書;

3、產品要求：必須要有合乎業(yè)務范圍的產品信息，并出具證書;

4、其他相關法律法規(guī)要求。

三、辦理三類醫(yī)療器械許可證的流程：

1、申請人提交申請資料到相關部門;

2、相關部門受理申請人的申請;

3、到實際場地進行勘察以及對產品進行審核;

4、準予頒發(fā)三類醫(yī)療器械許可證。

以上就是對三類醫(yī)療器械經營許可證辦理的相關介紹，辦理的程序可能較為繁瑣。

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