提供材料

1.二類醫(yī)療器械備案申請書

2.營業(yè)執(zhí)照或預(yù)先核名通知書

3.法定代表人、企業(yè)負責人、質(zhì)量負責人的身份證明、學(xué)歷或者職稱證明復(fù)印件

4.經(jīng)營場所、庫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)營目錄表

6.產(chǎn)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(shè)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(zhì)，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(guān)人員(公司負責人、質(zhì)量負責人、質(zhì)量檢查人員)

devices 2. Business license or pre-check name notice 3. Copy of the identity certificate, education background or professional title certificate of the legal representative, the person in charge of the enterprise and the person in charge of 4. Copy of the geographical location map, floor plan, house property right certificate or lease agreement (attached with the house property right certificate). 5 6. Product certificate 7. Last home purchase and sales contract and purchase channels Note: The validity period of class II medical devices is long-term, and the new record certificate of Class II medical devices shall be issued to the municipal food and drug regulatory department 6 months before the expiration 3. The company has increased the business scope of the three types of medical devices Re for the Busines