Application form for purchasing medical purification equipment

Two copies of оシシシシシシシシシシシシシシシシシシシ. Data 3. The original and six copies of the pre-approval notice of enterprise name No.7 or business license issued by the administrative department for industry and commerce; No.8, 1 piece of production site certificate, including 2 copies of property right certificate or lease agreement, and the lessor's property right certificate 1 piece; The general plan of Area G J of the factory, and 8 copies of the plan layout of the main production vehicle B and the vehicle V with cleanliness requirements, which must indicate the logistics direction of the function room and I-person V; 0 copies of the registration form for inter-provincial establishment of production sites for Class II and Class III medical device manufacturing enterprises (applicable to enterprises planning to establish production sites across provinces); No.6 document. Six copies of resume P, diploma H or title certificate F of the person in charge of the production, technology and quality department of the enterprise; Three registration forms for technicians I and V in related special industries; Member D of the relevant person must register five N-lists (Z is in application area D) and indicate the positions of J and O in the department; 5. The proportion of senior, middle and junior technicians F is 2 copies each; Six copies of internal 1 auditor certificate 3 meeting the requirements of quality management system; No.0, product range, varieties and related product introductions in 4 copies (product introduction 4, at least 2 copies including product structure, principle, expected use and product standards); If it is planned to produce in vitro diagnostic reagents, it is also necessary to provide 2 copies of Q list of enterprises planning to produce in vitro diagnostic reagents, as shown in Schedule 5; Data 2, list of main production equipment and testing instruments in quintuplicate; Data No.5, 7 production quality management specifications and 8 catalogues, including 5 items of procurement, acceptance, production process, product inspection, warehousing, warehousing, quality tracking, 8 feedback from users, adverse event monitoring and quality accident reporting system; Data number 1, process flow chart of the product to be produced in 3 copies, and indicate the main control items and control points, including the description of key and special equipment of process A, personnel I and parameter control of process A; No.70. Copy of 1 environmental test report issued by provincial food and drug supervision and management departments (such as Jiangsu Medical Device Quality Supervision and Inspection Institute, Jiangsu Drug Inspection Institute, etc.) if there are requirements for purification 6 in the production process. ) It shall provide a P-year (including: P test report 1 copy in Z room of No.2 vehicle of S purification in production area, and V test report 1 copy in F-class purification 0 bacteria laboratory). If it is necessary to produce fluorine-free medical devices in the environment, it should meet the requirements of YY00 18 "Production Management Specification for Fluorine-free Medical Devices"; The production environment of in vitro diagnostic reagents shall meet the requirements of Appendix A of Detailed Rules for the Production of in vitro diagnostic reagents (for Trial Implementation). The material number is 6 1, and six self-assurance statements about the authenticity of the application materials, including the catalogue of application materials and the enterprise's commitment to bear legal responsibility for any falsehood; No.62 document Q applies for enterprise application materials. If the manager K is not the legal representative G or the person in charge K himself X, the enterprise submits 6 copies of power of attorney 1. There are 42 self-inspection confirmations of medical device manufacturers with the data number of 15 and truthfully filled in, and 42 confirmations of application for inspection. Requirements for application materials: