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
三、公司增加三类医疗器械经营范围
三类医疗器械经营许可证要求：
1、场地要求：必须是办公性质，使用面积要Zui少达到60平方米;
icate, education background or professional title certificate ofthe legal representative, the person in charge of the enterpriseand the person in charge of quality 4. Copy of the geographicallocation map, floor plan, house property right certificate or leaseagreement (attached with the house property right certificate). 56. Product qualification certificate 7. Last home purchase andsales contract and purchase channels Note: The validity period ofclass 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 3. The company has increa
