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)的备案并且持有证书;
3、产品要求：必须要有合乎业务范围的产品信息，并出具证书;
rtificate or lease agreement (attached with the house propertyright certificate). 5 6. Product qualification certificate 7. Lasthome purchase and sales contract and purchase channels Note: Therecord validity period of class II medical devices is long-term,and the new record certificate of Class II medical devices shall beissued to the municipal food and drug regulatory department 6months before the expiration 3. The company has increased thebusiness scope of the three types of medical devices Requirementsfor the Business License of Class III Medical Device: 1, the siterequirements: must be the office nature, the use of the area toreach at least 60 square meters; 2. Personnel requirements: 3relevant
