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
tion services, 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 equipped withwarehouses suitable for the business scale. Provide materials: 1.Enterprise name and business scope, registered capital andproportion of shareholder contribution, shareholders and otheridentity certificates; 2. Medical device product registrationcertificate, supplier business license, license and authorizationletter; 3. Quality management documents, etc.; 4,2 or morecertificates, identification certificate and resume of medicalprofessionals or related professionals; 5. Certificate of officespace and warehouse meeting the business requirements of medicaldevice operation; 6. Articles of association, resolutions ofshareholders' meeting, etc.; 7. ID card and post card of financialpersonnel; 8. Other relevant materials. 1. There will be differentdifferences in different food and drug institutes of the submittedmaterials, subject to on-site verification. 2. Operation
