是具有較高風(fēng)險(xiǎn),，需要采取特別措施嚴(yán)格控制管理以保證其安全、有效的醫(yī)療器械,。比如常見的銷售xinguan實(shí)際檢測(cè)盒、隱形眼鏡,、注射器,、靜脈留置針、心臟支架,、呼吸機(jī),、CT、核磁共振等,。

醫(yī)療器械經(jīng)營(yíng)許可證現(xiàn)為后置審批,，有效期為5年。有效期屆滿需要延續(xù)的,，依照有關(guān)行政許可的法律規(guī)定辦理延續(xù)手續(xù),。

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;

cal 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;