4.經(jīng)營(yíng)場(chǎng)所、庫(kù)房地址的地理位置圖、平面圖、房屋產(chǎn)權(quán)證明文件或者租賃協(xié)議(附房屋產(chǎn)權(quán)證明文件)復(fù)印件 5.產(chǎn)品經(jīng)營(yíng)目錄表

6.產(chǎn)品合格證書

7.上家購(gòu)銷合同、進(jìn)貨渠道

注：二類醫(yī)療器械備案有效期為長(zhǎng)期，到期前6個(gè)月到所在地設(shè)區(qū)的市級(jí)食品藥品監(jiān)督管理部門換發(fā)二類醫(yī)療器械備案新憑證

三、公司增加三類醫(yī)療器械經(jīng)營(yíng)范圍

三類醫(yī)療器械經(jīng)營(yíng)許可證要求：

1、場(chǎng)地要求：必須是辦公性質(zhì)，使用面積要最少達(dá)到60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;

business scope of the three types of medical devices Re for the Business License of Class III Medical Device: 1, site re: must be office nature, the use area of at least 60 square meters; 2. Personnel re: 3 relevant personnel (company responsible person, responsible person, inspection personnel) need to record and hold the certificate; 3, product re: must have the product information in accordance with the business scope, and issue a certificate;