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
6.产品合格证书
7.上家购销合同、进货渠道
注：二类医疗器械备案有效期为长期，到期前6个月到所在地设区的市级食品药品监督管理部门换发二类医疗器械备案新凭证
e, storage 40 square 2.2 medical professionals are the leadersof the enterprise 3. Product management catalogue Note: If the lineof the above 3 points, basically can handle the record of class IImedical devices Provide materials 1. Application form for filing ofClass II medical devices 2. Business license or pre-check namenotice 3. Copy of the identity certificate, education background orprofessional title certificate of the legal representative, theperson in charge of the enterprise and the person in charge ofquality 4. Copy of the geographical location map, floor plan, houseproperty right certificate or lease agreement (attached with thehouse property right certificate). 5 6. Product qualificationcertificate 7. Last home purchase and sales contract and purchasechannels Note: The validity period of class II medical devices islong-term, and the new record certificate of Class II medicaldevices shall be issued to the municipal food and drug regulatorydep
