要求：
1.商用性质办公60平，仓储40平
2.2名医学专业人员为企业负责人
3.产品经营目录
注：符合以上3点，基本上就可以办理二类医疗器械备案
提供材料
1.二类医疗器械备案申请书
2.营业执照或预先核名通知书
3.法定代表人、企业负责人、质量负责人的身份证明、学历或者职称证明复印件
4.经营场所、库房地址的地理位置图、平面图、房屋产权证明文件或者租赁协议(附房屋产权证明文件)复印件5.产品经营目录表
sically can handle the record of class II medical devicesProvide materials 1. Application for filing of Class II medicaldevices 2. Business license or pre-check name notice 3. Copy of theidentity certificate, education background or professional titlecertificate of the legal representative, the person in charge ofthe enterprise and the person in charge of quality 4. Copy of thegeographical location map, floor plan, house property rightcertificate or lease agreement (attached with the house propertyright certificate). 5
