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
usiness scope, registered capital and proportion of shareholdercontribution, shareholders and other identity certificates; 2.Medical device product registration certificate, supplier businesslicense, license and authorization letter; 3. Quality managementdocuments, etc.; 4,2 or more certificates, identificationcertificate and resume of medical professionals or relatedprofessionals; 5. Certificate of office space and warehouse meetingthe business requirements of medical device operation; 6. Articlesof association, resolutions of shareholders' meeting, etc.; 7. IDcard and 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 implementation rules of Beijing Municipal Supervision andManagement Measures of Medical
