4.經(jīng)營場所、庫房地址的地理位置圖、平面圖、房屋產權證明文件或者租賃協(xié)議(附房屋產權證明文件)復印件 5.產品經(jīng)營目錄表

6.產品合格證書

7.上家購銷合同、進貨渠道

注：二類醫(yī)療器械備案有效期為長期，到期前6個月到所在地設區(qū)的市級食品藥品監(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)營范圍

三類醫(yī)療器械經(jīng)營許可證要求：

1、場地要求：必須是辦公性質，使用面積要最少達到60平方米;

2、人員要求：需要有3名相關人員(公司負責人、質量負責人、質量檢查人員)的備案并且持有證書;

3、產品要求：必須要有合乎業(yè)務范圍的產品信息，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;