通州八里桥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

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地及仓库证明; 　6、公司章程、股东会决议等;

7、财务人员身份证和上岗证;8、其它相关材料。

1、提交的材料不同的食药所会有不同的差别，具体以现场核查

ment, Class III-6846 implant materials artificial organs, ClassIII-6863 stomatology materials, class III-6877 interventionalequipment products, the use area of the business site shall not beless than 100 square meters, and the warehouse area shall not beless than 40 square meters. 2. Business class code for three-6815injection puncture instruments, three-6845 extracorporealcirculation and liquid treatment equipment, three-6864 medicalhealth materials and dressings, three-6865 medical suture materialsand adhesives, three-6866 medical polymer materials and products,premises use area of not less than 60 square meters, warehouse usearea shall not be less than 80 square meters. 3. Engaged in theretail business of Class III-6822 medical optical instruments andendoscopic equipment (soft contact lenses only), there shall beindependent counters; for providing inspection and distributionservices, the use area of the business site shall not be less than30 square meters, and the optometry room (area) shall meet the darkroom conditions or meet the conditions of no direct lighting. 4.For the operation of three types of medical devices other than theabove code, the use area of the business site shall not be lessthan 60 square meters, and shall be equipped with warehousessuitable for the business scale. Provide materials: 1. Enterprisename and business scope, registered capital and proportion ofshareholder contribution, shareholders and other identitycertificates; 2. Medical device product registration certificate,supplier business license, license and authorization letter; 3.Quality management documents, etc.; 4,2 or more certificates,identification certificate and resume of medical professionals orrelated professionals; 5. Cert