What are the procedures for the registration and declaration of medical devices?

Medical device registration process GJPC (Guojian Pharmaceutical Consulting), medical device registration certificate have to prepare what materials or information?　1, first to your city Food and Drug Administration, get the application form and electronic text (you can also go to the website to download). Then prepare the materials according to the following.　Declaration materials (1) "Medical Device Manufacturer License" (start-up) application form; (2) the legal representative, the person in charge of the enterprise's basic information and proof of qualifications, including proof of identity, proof of academic qualifications, proof of title, a copy of the appointment documents, work resume; (3) business administration department issued the notice of approval of the enterprise's name or the original and a copy of the business license; (4) the production site supporting documents (4) Documents proving the production site, including a copy of the property certificate or lease agreement and the property certificate of the leased party, the general layout of the factory, and the layout of the main production workshops. Workshops with clean requirements, must be marked with functional rooms and people flow towards; (5) enterprise production, technology, quality department responsible for the resume, a copy of the certificate of academic qualifications and titles; relevant professional and technical personnel, skilled workers, registration form, a copy of the certificate, and marked in the department and position; high, medium and junior technical personnel ratio of the table; a copy of the certificate of the internal auditor; (6) the scope of the products to be produced, the variety and (6) the scope of products to be produced, varieties and related product profile. The product profile includes at least a description of the product's structural composition, principles, intended use and product standards; (7) A list of the main production equipment and inspection instruments; (8) A catalog of documents on production quality management standards: including documents on purchasing, acceptance, production process, product inspection, warehousing, warehousing, quality tracking, user feedback, monitoring of adverse events and quality accident reporting system, and the enterprise's organizational chart; (9) Process flow diagram of the proposed product, and indicate the main control items and control points. Including key and special process equipment, personnel and process parameters control instructions; (10) to produce sterile medical devices, need to provide a clean room qualified test report. By the provincial food and drug supervision and management department recognized testing organizations issued within one year in line with the "production of aseptic medical devices management norms" (YY0033) qualified test report; (11) application materials for the authenticity of the self-assurance statement. List the catalog of declaration materials, and materials to make a commitment to bear legal responsibility for any false. 2, secondly, your product needs to have a class of medical device registration certificate: Class I medical device registration application materials (a) the territory of the medical device registration application form; (b) proof of qualification of medical device manufacturers: a copy of the business license; (c) the applicable product standards and instructions: the use of national standards, industry standards as the applicable standards of the product should be submitted to the national standards adopted by the national standards, the text of industry standards; Registered product standards should be signed by the manufacturer. Manufacturing enterprises should provide the application of products in line with national standards, industry standards, the statement that the manufacturer assumes responsibility for the quality of the products listed on the statement as well as the relevant product models, specifications and division of the description. Here the "signature" means: the enterprise seal, or its legal representative, the person in charge of the signature plus the enterprise seal (the following involves the territory of the medical device, the same meaning); (d) the full performance of the product test report; (e) the enterprise production of the product's existing resources and quality management capabilities (including testing methods) of the statement; (f) the medical device specification; (g) the application for the product to meet the national standards and industry standards, the manufacturer to assume responsibility for the quality of the product after marketing, and the product type, specification classification. (F) instructions for medical devices; (G) the authenticity of the materials submitted by the self-assurance statement: should include a list of materials submitted, the commitment of the manufacturer to assume legal responsibility. 3, the Technical Supervision Bureau to apply for testing