通州果园北京医疗器械三类经营许可证，医疗器械二类备案提供进销存软件人员专业快捷包下证
.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)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;
4、其他相关法律法规要求。
经营三类类医疗器械的，应具备与经营规模相适应的经营场所和库房
1.经营类代号为三类-6821医用电子仪器设备、三类-6846植入材料人工器官、三类-6863口腔科材料、三类-6877介入器材产品的，经营场所使用面积不得少于100平方米，库房使用面积不得少于40平方米。
2.经营类代号为三类-6815注射穿刺器械、三类-6845体外循环及液处理设备、三类-6864医用卫生材料及敷料、三类-6865医用缝合材料及粘合剂、三类-6866医用高分子材料及制品的,经营场所使用面积不得少于60平方米，库房使用面积不得少于80平方米。
3.从事类代号为三类-6822医用光学器具、仪器及内窥镜设备(jinxian软性角膜接触镜)类零售业务的，应设有独立的柜
ase channels Note: The record validity period of class II medical devices is long-term, and the new record certificate of Class II medical devices shall be issued to the municipal food and drug regulatory department 6 months before the expiration 3. The company has increased the business scope of the three types of medical devices Requirements for the Business License of Class III Medical Device: 1, site requirements: must be office nature, the use area of at least 60 square meters; 2. Personnel requirements: 3 relevant personnel (company responsible person, quality responsible person, quality inspection personnel) need to record and hold the certificate; 3, product requirements: must have the product information in accordance with the business scope, and issue a certificate; 4. Other relevant laws and regulation requirements. For three types of medical devices, it shall have a business site and warehouse suitable with the scale of operation 1. If the business code is class III-6821 medical electronic equipment, Class III-6846 implant materials artificial organs, Class III-6863 stomatology materials, class III-6877 interventional equipment products, the use area of the business site shall not be less than 100 square meters, and the warehouse area shall not be less than 40 square meters. 2. Business class code for three-6815 injection puncture instruments, three-6845 extracorporeal circulation and liquid treatment equipment, three-6864 medical health materials and dressings, three-6865 medical suture materials and adhesives, three-6866 medic
