Then prepare the materials according to the following.
Declaration materials
(1) Application form for "Medical Device Manufacturer License" (start-up);
(2) Basic information and qualification certificates of legal representatives and persons in charge of the enterprise, including identity certificates, certificates of education, certificates of titles, copies of appointment documents, and work resumes;
(3) Enterprise name issued by the administrative department for 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 events 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.
(2) Secondly, your product needs to have a class I medical device registration certificate:
Class I medical device registration application materials
(a) 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 instructions:
Adoption of national standards, industry standards as the applicable standards for products, should be submitted to the adopted national standards, industry standards of the text; registered product standards should be signed by the manufacturer.
Producers should provide the statement that the product applied for is in line with national standards, industry standards, the statement that the producer bears the responsibility for the quality of the product after the market, as well as the description of the relevant product model, specification division.
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 enterprise's production of the product'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 manufacturer's commitment to assume legal responsibility.
(3) Technical Supervision Bureau to apply for testing
Application materials
(a) product testing standards
Above (1), (2) is in the Food and Drug Administration Medical Devices Division
(3) is in the Municipal Administration of Technical Supervision