一、三類(lèi)醫療器知械許可證注冊所需材料

1、企業(yè)名稱(chēng)與經(jīng)營(yíng)范圍，注冊資本及股東出資比例，股東等身份證明;

2、醫療器械產(chǎn)品注冊證書(shū)、供應商營(yíng)業(yè)執照、許可證及授權書(shū);

3、質(zhì)量管理文件等;

4、2個(gè)或以上醫學(xué)專(zhuān)業(yè)或相關(guān)專(zhuān)業(yè)人員證書(shū)、身份證明與簡(jiǎn)歷;

5、符合醫療器械經(jīng)營(yíng)要求的辦公場(chǎng)地及倉庫證明;

6、公司章程、股東會(huì )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(lèi)醫療器械許可證的要求：

1、場(chǎng)地要求：必須是辦公性質(zhì)，使用面積要少達到45平方米;

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

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(shū);

4、其他相關(guān)法律法規要求。

usiness scope, registered capital and proportion of shareholder contribution, shareholders and other identity certificates; 2. Medical device product registration certificate, supplier business license, license and authorization letter; 3. management documents, etc.; 4,2 or more certificates, identification certificate 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,