Business license handling process:
Material number 1, application form for medical device business license in duplicate, and one electronic declaration document for medical device business license.
Material 2. The original and 1 copy of the enterprise name pre-approval notice 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.
No.8, 1 management quality management standard document, including procurement, acceptance, warehousing, storage, quality tracking, user feedback, adverse event monitoring and quality accident reporting system;
9. Inventory of storage facilities and equipment.
The material number is 10, and the declaration of self-assurance of the authenticity of the application materials is 1, including the catalogue of the application materials and the enterprise's commitment to bear legal responsibility if the materials are false;
The material number is 1 1. If the handler of enterprise application materials is not the legal representative or the person in charge, the enterprise shall submit 1 power of attorney.
MaterialNo. 12, Application for Medical Device Business License Confirmation
It's a bit troublesome to get this certificate. ...
The above materials are application materials, and the on-site audit needs to arrange offices and warehouses.
It is also necessary to formulate relevant laws and regulations, quality management system, training records, warehouse management system, medical device management system and other documents.