要求：

1.商用性質(zhì)辦公60平，倉儲40平

2.2名醫(yī)學(xué)專業(yè)人員為企業(yè)負責(zé)人

3.產(chǎn)品經(jīng)營目錄

注：符合以上3點，基本上就可以辦理二類醫(yī)療器械備案

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(zé)人、質(zhì)量負責(zé)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

 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