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(jīng)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(chǎn)品注冊證書,、供應(yīng)商營業(yè)執(zhí)照,、許可證及授權(quán)書;

3、質(zhì)量管理文件等;

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

5、符合醫(yī)療器械經(jīng)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(wù)人員身份證和上崗證;

8,、其它相道關(guān)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(zhì),，使用面積要少達(dá)到45平方米;

2、人員要求：需要有3名相關(guān)人員(公司負(fù)責(zé)人,、質(zhì)量負(fù)責(zé)人,、質(zhì)量檢查人員)的備案并且持有證書;

3、產(chǎn)品要求：必須要有合乎業(yè)務(wù)范圍的產(chǎn)品信息，并出具證書;

4,、其他相關(guān)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(guān)部門;

2,、相關(guān)部門受理申請人的申請;

3、到實際場地進(jìn)行勘察以及對產(chǎn)品進(jìn)行審核;

4,、準(zhǔn)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(jīng)營許可證辦理的相關(guān)介紹，辦理的程序可能較為繁瑣,。

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