Data number 1, medical device business license application form, medical device business license.
2. Notice of pre-approval of enterprise name or business license issued by the administrative department for industry and commerce.
No.3, application report.
4. Proof documents of the business premises and storage premises, including the copy of the title certificate or lease agreement and the title certificate of the lessor.
Data 5. Layout of business premises and warehouses.
Copy of ID card, graduation certificate or professional title certificate and resume of the person in charge of the proposed method, the person in charge of the enterprise and the quality manager in Document 6.
7. List of technical personnel and copies of academic qualifications and professional title certificates.
Data No.8. Directory of Management Quality Management Specification Documents.
9. The product invoicing information management system installed by the enterprise, and the homepage of the information management system is printed.
Material number 10, storage facilities and equipment catalogue.
Data number 1 1, on-the-job self-assurance statement of quality management personnel and self-assurance statement of authenticity of application materials, including the catalogue of application materials and the enterprise's commitment to bear legal responsibility for any falsehood;
The material number is 12. If the handler of enterprise application materials is not the legal representative or the person in charge himself, the enterprise shall submit a power of attorney.
MaterialNo. 13, Application for Medical Device Business License Confirmation