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;
2、人员要求：需要有3名相关人员(公司负责人、质量负责人、质量检查人员)
ong-term, and the new record certificate of Class II medicaldevices shall be issued to the municipal food and drug regulatorydepartment 6 months before the expiration 3. The company hasincreased the business scope of the three types of medical devicesRequirements for the Business License of Class III Medical Device:1, the site requirements: must be the office nature, the use of thearea to reach at least 60 square meters; 2. Personnel requirements:3 relevant personnel (company responsible person, qualityresponsible person, quality inspection personnel)
