Seek help class 2 medical device production license processing, involving 2 different classified products, the final is to get a few production license ah

twoОn シa cave ┗ c gall ding xp decay raft zc gall ding applicant l submit materials directory: data number 4, "medical device manufacturing enterprise license (open j办8)Application Form" 4; data number 4, the legal representative j, the person in charge of the enterprise t of the identification, proof of education h certificate or certificate of title, the appointment of copies of the documents 4 and the work of the f resume y4; data number 3, the industrial and commercial Administrative department t issued by the "notice of pre-approval of enterprise name 7" or "industrial o business license" copy of the original and 6 copies; Data No. 8, the production site proof of text 1, including proof of real estate or lease agreement and the lessor 1 copy of the real estate certificate 2 copies; factory g area j general layout plan, the main production of the b room layout 8 copies, there is a clean requirement of the car v room, shall be marked with the function of the room and the i person v logistics towards; "the second d, the third class b medical device manufacturing enterprises across the province to set up production sites registration form" 0 copies (to be set up across the province of the production site of the enterprise applies); Data No. 6, the enterprise's production, technology, quality department a person in charge of the f of the curriculum vitae p, proof of academic qualifications h or a copy of the certificate of professional title 6 copies; relevant professional and technical personnel j, technical staff, technical workers v people h registration form 3 copies; relevant people d staff Registration a n overview form 5 copies (in the application form area d under the z load), and indicate the department j and o position; high, middle 7, junior technical personnel f staff than 2 example of the situation table 5 copies; in line with the requirements of the quality management system of the internal 1 auditor's certificate 3 copies of 6 copies; Data No. 0, the scope of the proposed production of products, varieties and related product profile 4 4 copies of each (the product profile 4 at least 2 including the structural composition of the product, the principle of the product, Intended use of the description and product standards); proposed production of in vitro diagnostic reagents, also need to provide the proposed production of in vitro diagnostic reagents enterprise situation a q overview table 2 copies, see 0 Schedule 5; Data No. 2, the list of major production equipment and o inspection instruments 5 copies; Data No. 5, the production of quality management specification text 7 catalog 8 copies, including procurement, acceptance, production process, product inspection, into i storage, out of storage, quality tracking, User 8 feedback 2, adverse events monitoring and quality incident reporting system 5; Data No. 1, the proposed production of products, industrial u art k flow chart 3, and indicate the main control items and control points, including the key and special process a sequence of equipment, personnel and a description of the control of the industrial p art u parameters; Data No. 70, the production process of purification 6 requirements should be provided to the provincial food and drug supervision and management departments s recognized 8 acceptable testing organizations (such as: Jiangsu Provincial Medical Device Quality Supervision and Inspection Institute, Jiangsu Provincial Drug Inspection Institute, etc.) issued a p year 1 copy of the environmental test report (including: production area s purification 2 car z room test report a p copy of the 10,000 f purification 0 bacterial inspection room test report a v copy). If the proposed production of sterile medical devices environment, should meet the requirements of YY0018 "sterile medical device production management norms"; If the proposed production of in vitro diagnostic reagents environment, should meet the "in vitro diagnostic reagents production implementation rules (for trial implementation)" Appendix A requirements. Data No. 61, 6 copies of self-assurance statement of the authenticity of the application materials, including the catalog of application materials and the enterprise to make a commitment to the material if false to assume legal responsibility; Data No. 62, where q applying for the enterprise to declare the material, the office 5 person k staff is not t is the legal representative g or person in charge of the person k himself x, the enterprise should submit the "power of attorney 1" 6 copies. Data No. 15, truthfully filled in the opening o office 2 medical device manufacturer self-examination to confirm 1 42 copies of the application for inspection to confirm 2 copies of the book. Requirements for application materials: