西城广安门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，具体以现场核查为准。

2、第二类医疗器械经营备案凭证的申请都需要现场核

ct lenses only), there shall be independent counters; forproviding inspection and distribution services, the use area of thebusiness site shall not be less than 30 square meters, and theoptometry room (area) shall meet the dark room conditions or meetthe conditions of no direct lighting. 4. For the operation of threetypes of medical devices other than the above code, the use area ofthe business site shall not be less than 60 square meters, andshall be equipped with warehouses suitable for the business scale.Provide materials: 1. Enterprise name and business scope,registered capital and proportion of shareholder contribution,shareholders and other identity certificates; 2. Medical deviceproduct registration certificate, supplier business license,license and authorization letter; 3. Quality management documents,etc.; 4,2 or more certificates, identification certificate andresume of medical professionals or related professionals; 5.Certificate of office space and warehouse meeting the businessrequirements of medical device operation; 6. Articles ofassociation, resolutions of shareholders' meeting, etc.; 7. ID cardand post card of financial personnel; 8. Other relevant materials.1. There will be different differences in different food and druginstitutes of the submitted materials, subject to on-siteverification. 2. The application for the business registrationcertificate of category II medical devices