海淀厂洼北京医疗器械二类备案医疗器械三类经营许可证专业办理经验丰富速度快靠谱安全

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

evices Provide materials 1. Application for filing of Class IImedical devices 2. Business license or pre-check name notice 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 record validity period of class II medicaldevices is long-term, and the new record certificate of Class IImedical devices shall be issued to the