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查,一切情况以现场核查为准。3、医疗器械经营许可的申请,因为申请的类别不同对房屋的经营面积和库房面积要求不尽相同,具体参考《北京市〈医疗器械经营监督管理办法〉实施细则,和现场核查为准
meters, warehouse use area shall not be less than 80square meters. 3. Engaged in the retail business of Class III-6822medical optical instruments and endoscopic equipment (soft contactlenses only), there shall be independent counters; for theinspection services provided, the use area of the business siteshall not be less than 30 square meters, and the optometry room(area) shall meet the dark room conditions or meet the conditionsof no direct lighting. 4. For the operation of three types ofmedical devices other than the above code, the use area of thebusiness site shall not be less than 60 square meters, and shall beequipped with warehouses suitable for the business scale. Providematerials: 1. Enterprise name and business scope, registeredcapital and proportion of shareholder contribution, shareholdersand other identity certificates; 2. Medical device productregistration certificate, supplier business license, license andauthorization letter; 3. Quality management documents, etc.; 4,2 ormore certificates, 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. The application forthe business record certificate of category II medical devicesrequires on-site verification, and all information shall be subjectto on-site verification.3. For the application for the businesslicense of medical