一、三類醫(yī)療器知械許可證注冊(cè)所需材料

1、企業(yè)名稱與經(jīng)營(yíng)范圍，注冊(cè)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(cè)證書、供應(yīng)商營(yíng)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(gè)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(jiǎn)歷;

5、符合醫(yī)療器械經(jīng)營(yíng)要求的辦公場(chǎng)地及倉(cāng)庫(kù)證明;

6、公司章程、股東會(huì)決議等;

7、財(cái)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(chǎng)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(qǐng)人提交申請(qǐng)資料到相關(guān)部門;

2、相關(guān)部門受理申請(qǐng)人的申請(qǐng);

3、到實(shí)際場(chǎng)地進(jìn)行勘察以及對(duì)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(duì)三類醫(yī)療器械經(jīng)營(yíng)許可證辦理的相關(guān)介紹，辦理的程序可能較為繁瑣。

ate and resume of medical professionals or related professionals; 5. Office space and warehouse certificate that meet the business re of medical e; 6. Articles of association, resolutions of shareholders' meeting, etc.; 7. ID card and post card of financial personnel; 8, other phase channel clearance materials. 2. Re for three-of medical device license: 1, site re: must be office nature, the use area should be less than 45 square meters; 2. Personnel re: 3 relevant personnel (company responsible person, responsible person, inspection personnel) need to record and hold the certificate; 3, product re: must have the product information in accordance with the business scope, and issue a certificate; 4. Other relevant laws and regulations and re. 3. Procedures for Handling the Class III Medical Device License: 1. The applicant shall submit the application materials to the relevant departments; 2. Relevant departments shall accept the application of the applicant; 3. Investigate the actual site and audit the products; 4. Grant the issuance of a class