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
rials: 1. Enterprise name and business scope, registered capitaland proportion of shareholder contribution, shareholders and otheridentity certificates; 2. Medical device product registrationcertificate, supplier business license, license and authorizationletter; 3. Quality management documents, etc.; 4,2 or morecertificates, 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, which are specific and 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. For theapplication of medical device business license, differentcategories of the business area and the warehouse area have dif