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(shū)、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(lèi)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(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(guī)要求。

三、辦理三類(lèi)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(mén);

s, 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 th