西城金融街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

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;

duct information in accordance with the business scope, andissue a certificate; 4. other relevant laws and regulations andre for operating three types of medical devices, itshall have a business site and warehouse suitable for the scale ofoperation 1. if the business code is class iii-6821 medicalelectronic e, class iii-6846 implant materials artificialorgans, class iii-6863 stomatology materials, class iii-6877interventional e products, the use area of the businesssite shall not be less than 100 square meters, and the warehousearea shall not be less than 40 square meters. 2. business classcode for three-6815 injection puncture instruments, three-6845extracorporeal circulation and liquid treatment e,three-6864 medical health materials and dressings, three-6865medical suture materials and adhesives, three-6866 medical polymermaterials and products, premises use area shall not be less than 60square meters, warehouse use area shall not be less than 80 s 3. engaged in the retail business of class iii-6822 medicaloptical instruments and endoscopic e (soft contact lensesonly), there shall be independent counters; for the inspectionservices provided, the use area of the business site shall not beless than 30 square meters, and the optometry room (area) shallmeet the dark room conditions or meet the conditions of no directlighting. 4. for the operation of three types of medical devicesother than the above code, the use area of the business site shallnot be less than 60 square meters, and shall be e withwarehouses suitable for the business scale. provide materials: 1.enterprise name and business scope, registered capital andproportion of shareholder contribution, shareholders and otheridentity certif