1, first go to your city Food and Drug Administration, get the application form and electronic text (you can also download from the website). Then prepare the materials according to the following.
Declaration materials ：
(1)《Medical Device Manufacturer License》(start-up)Application Form；
(2)Basic information and qualification certificates of the legal representative and the person in charge of the enterprise, including proof of identity, academic qualifications, professional title, a copy of the appointment document, and a work resume；
(3)Enterprise name approval notice or business license issued by industrial and commercial administration department. Name approval notice or business license original and copy;
(4)
Production site documents, including property certificates or lease agreements and copies of the property certificate of the leased party, the general layout of the plant, the main production workshop layout. Workshops with cleanliness requirements, must be marked with functional rooms and people and logistics
direction;
(5) the enterprise's production, technology, quality department responsible for the resume, a copy of the academic qualifications and titles of the certificates; relevant professional and technical personnel, skilled workers registration form, a copy of the certificate, and marked the department and position; high,
the proportion of junior and middle level technical staff table; Copies of internal auditor certificates;
(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)
Production of quality management specification document catalog:
Including procurement, acceptance, production process, product inspection, warehousing, warehousing, quality tracking, user feedback, adverse event monitoring and quality incident reporting system. 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) 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 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 filing materials, and materials to make a commitment to bear legal responsibility if false.
2, followed by 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) medical device manufacturer qualification certificate: copy of the business license;
(c)
Applicable product standards and instructions: the use of national standards, industry standards as the product of the Applicable standards, 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 that the producer bears the 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 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 manufacturer to assume legal responsibility for the commitment.
3, the Technical Supervision Bureau to apply for testing