醫療器械經(jīng)營(yíng)許可證現為后置審批，有效期為5年。有效期屆滿(mǎn)需要延續的，依照有關(guān)行政許可的法律規定辦理延續手續。

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：

ars. If the term of validity needs to be extended upon the expiration of the term, the extension procedures shall be handled in accordance with the relevant legal provisions of the administrative license. 1. Materials required for the registration of third III medical e license 1. Enterprise name and business 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 ph