1. Application form for medical device production license (application form with bar code must be printed in the information system);
2. Copy of business license (domicile must be in this province) and organization code certificate;
3 copies of the medical device registration certificate and product technical requirements (including in vitro diagnostic reagent product specifications) produced by the applicant enterprise;
4 copies of the identity certificates of the legal representative and the person in charge of the enterprise;
5. A copy of the identity, education and professional title certificate of the person in charge of production, quality and technology;
6. List of academic qualifications and titles of employees in production management and quality inspection positions;
7. Certification documents of production site, including copies of lease agreement and property right certificate (or use right certificate); The location and general plan of the factory and the layout of the main production workshops; If there are special production environment requirements, copies of supporting documents of facilities and environment shall also be submitted;
8. Catalogue of main production equipment and inspection equipment (the two are separated);
9. Procedure documents of quality manual and quality management system;
10. process flow chart: the purchased parts, key processes, special processes and production environment requirements of each process shall be indicated;
1 1. Agent's authorization certificate;
12. Self-assurance statement on the authenticity of the application materials;
13. Submit the paper version and the electronic version of the conformity statement.