Declaration materials
(1) "Medical Device Manufacturer's 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 name issued by the administrative department of industry and commerce Approval of the original and a copy of the notice or business license;
(4) production site documents, including property certificates or lease agreements and a copy of the property certificate of the leased party, the general layout of the plant, the main production workshop layout. 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 qualifications and titles; relevant professional and technical personnel, skilled workers registration form, a copy of the certificate, and indicate the department and position; the proportion of senior, middle and junior technical personnel table; a copy of the certificate of the internal auditor;
(6) the scope of products to be produced, varieties and related product profiles. The product profile includes at least a description of the product's structural composition, principles, intended use and product standards;
(7) the list of major production equipment and inspection instruments;
(8) production quality management standardized document catalog:
including procurement, acceptance, production process, product inspection, warehousing, warehousing, quality tracking, user feedback, adverse event monitoring and Quality Accident Reporting System and other documents, enterprise organization chart;
(9) The process flow diagram of the proposed product, with the main control items and control points. Including critical and special process equipment, personnel and process parameters control instructions;
(10) to produce sterile medical devices, need to provide a qualified test report of the clean room. Recognized by the provincial food and drug supervision and management department of the testing agency issued within one year in line with the "production of aseptic medical devices management norms" (YY0033) of the qualified test report;
(11) application materials for the authenticity of the self-assurance statement. List the catalog of application materials, and materials to make a commitment to bear legal responsibility for any false.
Two, followed by your product needs to have a class I medical device registration certificate:
(a) the application form for registration of medical devices within the territory;
(b) proof of qualification of medical device manufacturers: a copy of the business license;
(c) the applicable product standards and descriptions:
the adoption of national standards, industry standards as the applicable standards for the product. Should be submitted to the text of the adopted national standards, industry standards; registered product standards should be signed by the manufacturer.
Producers should provide the application of the product in line with national standards, industry standards, the statement of the producer to assume responsibility for the quality of the product on the market after the statement as well as the relevant product model, specification division of the description.
Here the "seal" means: the enterprise seal, or its legal representative, the person in charge of the signature and enterprise seal (the following medical devices, the same meaning);
(d) the full performance of the product test report;
(e) the production of the product of the enterprise's existing resources and quality management capabilities (including testing methods). Management capabilities (including testing methods) of the description;
(F) medical device instructions;
(VII) submitted materials to the authenticity of the self-assurance statement:
Should include a list of materials submitted, the commitment of the manufacturer to assume legal responsibility.
Third, the Technical Supervision Bureau to apply for testing
Application materials
(a) product testing standards
One and two of the above in the Food and Drug Administration and Medical Devices Division, and three in the Municipal Bureau of Technical Supervision