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，应设有独立的柜台;其中提供验配服务的，经营场所使用面积不得少于30平方米，验光室(区)应具备暗室条件或满足无直射照明的条件。
4.经营除上述类代号以外其他三类类医疗器械的，经营场所使用面积不得少于60平方米，并配备与经营规模相适应的仓库。提供材料：
1、企业名称与经营范围，注册资本及股东出资比例，股东等身份证明;
2、医疗器械产品注册证书、供应商营业执照、许可证及授权书;
3、质量管理文件等;
4、2个或以上医学专业或相关专业人员证书、身份证明与简历;
5、符合医疗器械经营要求的办公场
d hold a certificate; 3, product requirements: must have theproduct information in line with the business scope, and issue acertificate; 4, other relevant laws and regulations requirements.Management of three kinds of medical equipment, should have adaptedto the scale of business premises and warehouse 1. Business classcode for three-6821 medical electronic equipment, three-6846implant material artificial organs, three-6863 dental materials,three-6877 interventional equipment products, business premises usearea shall not be less than 100 square meters, warehouse use areashall not be less than 40 square meters.2. Business class code forthree-6815 injection puncture instruments, three-6845extracorporeal circulation and liquid treatment equipment,three-6864 medical health materials and dressings, three-6865medical suture materials and adhesives, three-6866 medical polymermaterials and products, premises use area of not less than 60square meters, warehouse use area shall not be less than 80 squaremeters.3. Engaged in the retail business
