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
or filing of Class II medical devices 2. Business license orpre-check name notice 3. Copy of the identity certificate,educational background or professional title certificate of thelegal representative, the person in charge of the enterprise andthe person in charge of 4. Copy of the geographicallocation map, floor plan, house property right certificate or leaseagreement (attached with the house property right certificate). 56. Product certificate 7. Last home purchase andsales contract and purchase channels Note: The record validityperiod of class II medical devices is long-term, and the new recordcertificate of Class II medical devices shall be issued to themunicipal food and drug regulatory department 6 months before theexpiration
