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。
一、
办理医疗器械三类经营许可证需要哪些材料?
1.法定代表人、企业负责人、质量负责人、售后服务人员等人员的身份证明、学历或者职称证明原件照片或复印件
2.组织机构与部门设置说明
3.经营范围、经营方式说明
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.经营设备、设备目录
6.经营质量管理制度、工作程序等文件目录
7.计算机信息管理系统基本情况介绍和功能说明
8.经办人授权证明
9.材料真实性声明
nts and endoscopic equipment (soft contact lenses only), thereshall be independent counters; for providing inspection anddistribution services, the service area of the business site shallnot be less than 30 square meters, and the optometry room (area)shall meet the dark room conditions or meet the conditions of nodirect lighting. 4. For the operation of three types of medicaldevices other than the above code, the use area of the businesssite shall not be less than 60 square meters, and shall be equippedwith warehouses suitable for the business scale. What materials isneeded for handling medical equipment three types of businesslicense? 1. The original photo or copy of the identity certificate,education background or professional title certificate of the legalrepresentative, the person in charge of th