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
nals; 5. Certificate of office space and warehouse meeting thebusiness requirements of medical device operation; 6. Articles ofassociation, resolutions of shareholders' meeting, etc.; 7. ID cardand working card of financial personnel; 8. Other relevantmaterials. 1. There will be different differences in different foodand drug submitted materials, and the specific ones is subject toon-site verification. 2. The application for the business recordcertificate of category II medical devices requires on-siteverification, and all information shall be subject to on-siteverification.3. For the application of medical device businesslicense, different categories of the business area and thewarehouse area have different requirements. For details, refer tothe
