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 e 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. 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 re 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