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。

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,