Data No. 2, legal representative, the person in charge of the enterprise's identity, proof of education or title, a copy of the appointment document and a copy of the work resume;
Data No. 3, the administrative department of industry and commerce issued by the "pre-approval of the enterprise's name notification" or "industrial and commercial Business License" copy of the original and 1 copy;
Data No. 4, the production site documents, including proof of property or lease agreement and a copy of the lessor's property certificate 1 copy; factory general layout, the main production workshop layout 1 copy, there are clean workshop requirements, must be marked with functional rooms and people flow towards; "the second class, the third class of medical device manufacturers across the province to set up production sites Registration Form" 4 (to set up production sites across the provinces of the enterprise applies);
Data No. 5, the enterprise's production, technology, quality department responsible for the curriculum vitae, copies of academic certificates or certificates of title 1; relevant professional and technical personnel, skilled workers registration form 1; the relevant personnel registration checklist 1 (in the application form area to download), and indicate the department and position; high, medium and junior The proportion of technical personnel 1; meet the quality management system requirements of the internal auditor's certificate 1 (applicable to the third class of medical device manufacturers);
Data No. 6, the scope of products to be produced, varieties and related product profile 1 (product profile at least include the structural composition of the product, principle, intended use of the description and product standards); proposed production of in vitro diagnostic reagents, also need to provide the proposed in vitro diagnostic reagent production To produce in vitro diagnostic reagents, you need to provide a list of enterprises to produce in vitro diagnostic reagents,
Data No. 7, a list of the main production equipment and testing instruments;
Data No. 8, a catalog of production quality management standard documents, including procurement, acceptance, production process, product testing, warehousing, warehousing, quality tracking, user feedback, monitoring of adverse events and quality accident reporting system, etc. Documentation;
Data No. 9, the proposed production of a product process flow diagram, and indicate the main control items and control points, including key and special process equipment, personnel and process parameters control instructions;
Data No. 10, the production process of purification requirements should be provided by the provincial food and drug supervision and management department recognized testing organizations within one year of the environmental testing report issued by the Copy.
Such as the environment of the proposed production of sterile medical devices, should meet the requirements of YY0033 "Sterile Medical Apparatus Production Management Code";
Such as the environment of the proposed production of in vitro diagnostic reagents, should meet the requirements of the "In Vitro Diagnostic Reagent Production Implementation Rules (for trial implementation)" Appendix A.
Data No. 11, 1 self-assurance statement of the authenticity of the application materials, including the directory of application materials and the enterprise to the material to make a commitment to bear legal responsibility for any false;
Data No. 12, where the application for the enterprise declaration of the material, the processing personnel is not the legal representative or person in charge of the person himself, the enterprise should be submitted to the "letter of authorization," a copy of Mr. Wu.
Data No. 13, truthfully filled out to start a medical device manufacturing enterprise self-examination confirmation 1 copy.