海淀万寿寺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
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 the product information in line with the business scope, and issue a certificate; 4, other relevant laws and regulations requirements. Management of three kinds of medical equipment, should have adapted to the scale of business premises and warehouse 1. Business class code for three-6821 medical electronic equipment, three-6846 implant material artificial organs, three-6863 dental materials, three-6877 interventional equipment products, business premises use area shall not be less than 100 square meters, warehouse use 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 medical polymer materials and products, premises use area of not less than 60 square meters, warehouse use area shall not be less than 80 square meters.3. Engaged in the retail business