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(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个或以上医学或相关人员证书、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
g. 4. For the operation of three types of medical devices otherthan the above code, the use area of the business site shall not beless than 60 square meters, and shall be equipped with warehousessuitable for the business scale. Provide materials: 1. Enterprisename and business scope, the registered capital and the proportionof shareholder 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. Certificate of office space and warehousemeeting the business requirements of medical device operation; 6.Articles of association, resolutions of shareholders' meeting,etc.; 7. ID card and post card of financial personnel; 8. Otherrelevant materials. 1. There will be different differences indifferent food and drug institutes of the submitted materials, andthe specific information shall be subject to on-site verification.2. The application for the business record certificate of categoryII medical devices requires on-site verification, and allinformation shall be subject to on-site verification.3. Applicationfor the business license of medical devices
