What materials or information should be prepared for the medical device registration certificate?
1, first of all to your city Food and Drug Administration, to get the application form and electronic text (you can also download to the site). 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 a notice of approval of the enterprise name or Original and copy of business license;
(4) documents proving the production site, including copies of property certificates or lease agreements and property certificates 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 human flow towards;
(5) the enterprise's 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 profile. Product profile at least includes a description of the product's structural composition, principle, intended use and product standards;
(7) the list of major production equipment and inspection instruments;
(8) production quality management standardized documents 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 charts;
(9) the product range, variety and related products. Documents, enterprise organization chart;
(9) the process flow diagram of the proposed product, and indicate the main control items and control points. Including critical and special process equipment, personnel and process parameters control instructions;
(10) proposed production of sterile medical devices, need to provide a clean room qualified test report. 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 sterile medical devices management standards" (YY0033) qualified test report;
(11) application materials for the authenticity of the self-assurance statement. Listed in the declaration materials catalog, and the material to make a commitment to bear legal responsibility if false. 2, followed by your product needs to have a class I medical device registration certificate:
Class I medical device registration application materials
(a) the territory of the application form for registration of medical devices;
(b) proof of qualification of medical device manufacturers: a copy of the business license;
(c) the applicable product standards and descriptions:
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.
The manufacturer shall provide the statement that the product applied for complies with the national standards and industry standards, the statement that the manufacturer assumes the responsibility for the quality of the product after it is marketed as well as the description of the relevant product model and 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 by the authenticity of the self-assurance statement: should include a list of materials submitted, the production company to assume legal responsibility for the commitment. 3, the Technical Supervision Bureau to apply for testing
Handling
Related documents are & lt; medical device registration management methods & gt;, which made detailed provisions
Article V The domestic production of the first class of medical devices for registration, should be submitted to the following materials:
(a) proof of qualification of medical device manufacturers.
(2) registered product standards and preparation instructions.
(C) product full performance self-test report.
(D) enterprise product production of existing resource conditions and quality management capabilities (including testing methods) description.
(E) product instructions.
(F) the authenticity of the materials submitted to the self-assurance statement.
Article VI of the domestic enterprises to produce the second class, the third class of medical devices shall submit the following materials for registration of trial production:
(a) medical device manufacturer qualification certificate.
(2) Product technical report.
(C) safety risk analysis report.
(D) Registered product standards and preparation instructions.
(E) product performance self-test report.
(F) State Drug Administration-recognized medical device quality testing organizations within the past year (biological materials for clinical trials within six months before) issued by the product trial production registered type test report.
(VII) more than two clinical trial base clinical trial report. The report provides the implementation of the "medical device registration clinical trial report sub-provisions" (see Annex), clinical trials to implement the "Medical Device Product Clinical Trial Management Measures".
(H) product instructions.
(ix) the submitted material authenticity of the self-assurance statement.
Article VII of the domestic enterprises to produce the second class, the third class of medical devices shall be submitted to the prospective registration of the following materials:
(a) medical device manufacturer qualification certificate.
(2) A copy of the trial production registration certificate.
(C) registered product standards.
(D) product improvement report during trial production.
(E) enterprise quality system assessment (certification) of effective documents.
(F) the State Drug Administration recognized medical device quality testing organizations within the last year issued by the product type test report for production registration.
(VII) product quality tracking report.
(viii) the submitted materials to the authenticity of the self-assurance statement.
(viii) Self-assurance statement of the authenticity of the submitted materials.