1, CFDA (ChinaFoodandDrugAdministration) certification
(1) In order to standardize the registration management of medical device products, to ensure the safety and effectiveness of medical devices, according to the "supervision and management of medical devices regulations", the State Food and Drug Administration to develop medical device registration management.
(2) March 22, 2013, the official website of the Food and Drug Administration also synchronized the name change, all changed to the State Food and Drug Administration, the English abbreviation from "SFDA" to "CFDA", even the original official microblogging "China", "China", "China", "China", "China", "China", "China", "China", "China", "China", "China", "China" and "China". The original official microblog "China Drug Administration" has also been changed to "China Food and Drug Administration".
2, CFDA in the medical device industry has multiple weight
(1) in China's territory sales, use of medical equipment products should be in accordance with the provisions of this approach to declare the registration of medical devices, without the approval of the registration of medical devices, shall not be sold and used. Medical device registration, refers to in accordance with the statutory procedures, the proposed market sales, use of medical devices for the safety and effectiveness of the systematic evaluation, in order to decide whether to agree to its sales, use of the process.
(2) It is divided into the registration of medical devices within the territory and the registration of medical devices outside the territory, medical devices outside the territory, regardless of Class I, Class II, Class III have to go to the State Food and Drug Administration in Beijing for the process: within the territory of the Class I, Class II medical devices in the local provincial or municipal Food and Drug Administration for the process, Class III to the State Food and Drug Administration for the process. The medical device registration certificate refers to the legal identity card of the medical machinery products.
3, first to the city Food and Drug Administration, get the application form and electronic text (you can also go to the website to download). Then material preparation.
(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 by the notice of approval of the enterprise name or business license Original and copy;
(4) documents proving the production site, including property certificates or lease agreements and copies of the property certificates of the leased party, the general layout of the factory, the main production workshop layout. Workshops with clean requirements, must indicate the function of the room and the direction of the flow of people;
(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, copies of certificates, 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. 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 incident reporting system Documents, enterprise organization chart;
(9) the process flow diagram of the product to be produced, 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 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.
Extended information:
Handling method
Related documents stipulate that < Medical device registration management measures>, which made detailed provisions
The domestic enterprises for the registration of the production of Class I medical devices, should be submitted to the following materials:
(a) medical device manufacturer qualification certificate.
(ii) 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.
Domestic enterprises to produce the second class, the third class of medical devices should be submitted to the trial production registration of the following materials:
(a) medical device manufacturer qualification certificate.
(ii) 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 registration 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 materials to the authenticity of the self-assurance statement.
Domestic enterprises to produce the second class, the third class of medical devices for the prospective registration should be submitted to the following materials:
(a) medical device manufacturer qualification certificate.
(ii) 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 past year issued by the product type test report for registration.
(VII) product quality tracking report.
(viii) the authenticity of the materials submitted to the self-assurance statement.
Baidu Encyclopedia - SFDA certification