要求：

1.商用性質辦公60平，倉儲40平

2.2名醫(yī)學專業(yè)人員為企業(yè)負責人

3.產品經(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)照或預先核名通知書

3.法定代表人、企業(yè)負責人、質量負責人的身份證明、學歷或者職稱證明復印件

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

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