要求：

1.商用性質(zhì)辦公60平，倉(cāng)儲(chǔ)40平

2.2名醫(yī)學(xué)專(zhuān)業(yè)人員為企業(yè)負(fù)責(zé)人

3.產(chǎn)品經(jīng)營(yíng)目錄

注：符合以上3點(diǎn)，基本上就可以辦理二類(lèi)醫(yī)療器械備案

提供材料

1.二類(lèi)醫(yī)療器械備案申請(qǐng)書(shū)

2.營(yíng)業(yè)執(zhí)照或預(yù)先核名通知書(shū)

3.法定代表人、企業(yè)負(fù)責(zé)人、質(zhì)量負(fù)責(zé)人的身份證明、學(xué)歷或者職稱(chēng)證明復(fù)印件

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(shū)

7.上家購(gòu)銷(xiāo)合同、進(jìn)貨渠道

torage 40 square 2.2 medical professionals are the leaders of the enterprise 3. Product management catalogue Note: To meet the above 3 points, basically can handle the record of class II medical devices Provide materials 1. Application form for filing of Class II medical 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 (attache