Medical device registration certificate, need to prepare what kind of material it

1, first of all to your city Food and Drug Administration, get the application form and electronic text (you can also download to the site). Then follow the following materials to prepare.

Declaration materials (1) "Medical Device Manufacturer License" (start-up) application form;

(2) legal representative, the person in charge of the enterprise's basic information and qualifications, including proof of identity, academic qualifications, title certificate, a copy of the appointment documents, work resume;

(3) business administration department issued a notice of approval of the business name or The original and copy of business license;

(4) production site documents, including property certificates or lease agreements and copies of property certificates of the leased party, the general layout of the factory, the main production workshop layout. Workshops with cleanliness requirements must be marked with functional rooms and human flow direction;

(5) the enterprise's production, technology, quality department responsible for the resume, academic qualifications and certificates of title; 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 internal auditors;

(6) the scope of products to be produced, including the lease agreement and the lease of the property certificate, the general layout of the plant, the main production plant layout plan. (6) the scope of products to be produced, varieties and related product profile. Product introduction at least include the product's structural composition, principles, intended use of the description and product standards;

(7) the main production equipment and inspection instruments list;

(8) production quality management standardized document catalog: including procurement, acceptance, production process, product inspection, warehousing, warehousing, quality tracking, feedback from the user, monitoring of adverse events and quality accident reporting system. Documents, enterprise organization chart;

(9) to produce products of the process flow diagram, and indicate the main control items and control points. Including key and special process equipment, personnel and process parameters control instructions;

(10) to produce 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 "sterile medical device production management specification" (YY0033) of the qualified test report;

(11) application materials to declare the authenticity of self-assurance. List of declaration materials catalog, and materials such as false commitment to bear legal responsibility. 2, secondly, your product needs to have a class of medical device registration certificate.

AuZhida medical device consulting organization