53Ʊ

What documents need to be prepared for medical device production license

1. Three "Application Forms for Medical Device Manufacturing Enterprise License (Start-up)";
2. Identity certificate, academic certificate or title certificate of the legal representative and the person in charge of the enterprise, a copy of the appointment document and a job resume;
3. The original and one copy of the "Notification of Pre-approval of Enterprise Name" or "Industrial and Commercial Business License" issued by the administrative department for industry and commerce;
4. Production site certification documents, including one copy of the real estate certificate or lease agreement and the lessor's real estate certificate; the general plan of the factory area, the layout of the main production workshop, and the workshop with cleanliness requirements, must indicate the function room and people logistics Trend; 4 "Registration Forms for the Establishment of Production Sites Across Provincial Types of Medical Equipment Manufacturers of the Second and Third Classes" (for companies that intend to establish production sites across provinces);
5. One copy of the resume, academic certificate or title certificate of the person in charge of the production, technology and quality departments of the enterprise; one copy of the relevant professional and technical personnel and skilled worker registration form; one copy of the relevant person registration list (download in the application form area) ), And indicate the department and position; 1 copy of the proportion of high, middle and junior technical personnel; 1 copy of the internal auditor's certificate that meets the requirements of the quality management system (applicable to third-class medical device manufacturers);
6. The scope of the product to be produced, the variety, and a brief introduction to the relevant product (the product profile at least includes a description of the product's structural composition, principle, intended use, and product standards); if it intends to produce in vitro diagnostic reagents, it also needs to provide the in vitro A list of diagnostic reagent companies,
7. A list of main production equipment and inspection instruments;
8. A catalogue of production quality management specifications documents, including procurement, acceptance, production process, product inspection, storage, delivery, quality tracking, user feedback, adverse event monitoring and quality incident reporting system;
9. A process flow chart of the product to be produced, and indicate the main control items and control points, including the key and special process equipment, personnel and process parameter control instructions;
10. If the production process requires purification, a copy of the environmental test report within one year issued by a testing agency approved by the provincial food and drug supervision and management department shall be provided. If the environment in which sterile medical devices are to be produced, it shall meet the requirements of YY0033 "Specifications for the Management of Production of Sterile Medical Devices"; if the environment in which it is intended to produce in vitro diagnostic reagents, it shall meet the requirements of Appendix A of the "Implementation Rules for the Production of In vitro Diagnostic Reagents (Trial)".
11. One self-assurance statement for the authenticity of the application materials, including the application material catalogue and the company's commitment to falsely bear legal responsibility for the materials;
12. When applying for enterprise application materials, the person in charge is not the legal representative or the person in charge, the enterprise should submit a "Power of Attorney" to Mr. Wu.
13. A self-examination confirmation letter for the establishment of a medical device manufacturing enterprise truthfully filled in.