1. Go to your municipal food and drug administration to get the application form and electronic text (which can also be downloaded from the website). Then prepare according to the following materials.

Application materials:

(1) Application Form for License of Medical Device Manufacturing Enterprise (for establishment);

(two) the basic information and qualification certificates of the legal representative and the person in charge of the enterprise, including identity certificate, education certificate, professional title certificate, copy of the employment documents and work resume;

(3) The original and photocopy of the enterprise name approval notice or business license issued by the administrative department for industry and commerce;

(4)

Certification documents of the production site, including the copy of the property right certificate or lease agreement and the lessee's property right certificate, the general plan of the factory and the layout of the main production workshops. Workshops with cleanliness requirements should be marked with functional rooms and people flow and logistics.

Arrive;

(5) Resume of the person in charge of the production, technology and quality departments of the enterprise, and a copy of education and professional title certificate; Copies of registration forms and certificates of relevant professional and technical personnel and skilled workers, and indicate their departments and positions; Tall,

Proportion table of intermediate and junior technicians; Copy of internal auditor's certificate;

(six) the scope of products to be produced, varieties and related products. The product introduction at least includes a description of the product structure, principle, expected use and product standards;

(7) List of main production equipment and testing instruments;

(8)

Production quality management specification file directory:

Including procurement, acceptance, production process, product inspection, warehousing, quality tracking, user feedback, adverse event monitoring and quality accident reporting system and other documents, enterprise organization chart;

(9) Process flow chart of the products to be produced, and indicate the main control items and control points. Including the description of equipment, personnel and process parameter control of key and special processes;

(10) If you plan to produce sterile medical devices, you need to provide a clean room qualification test report. A qualified inspection report issued by a testing institution recognized by the provincial food and drug administration that meets the "Management Standards for the Production of Sterile Medical Devices" (YY0033) within one year;

(1 1) Self-assurance statement on the authenticity of the application materials. List the application materials, and promise that if the materials are false, they will bear legal responsibility.

2. Secondly, your product needs a class of medical device registration certificate: a class of medical device registration application materials (1) domestic medical device registration application form;

(2) Qualification certificate of medical device manufacturing enterprise: a copy of business license;

(3)

Applicable product standards and descriptions: if national standards and industry standards are adopted as applicable standards for products, the texts of the adopted national standards and industry standards shall be submitted; The registered product standard shall be signed and sealed by the production enterprise.

The production enterprise shall provide a statement that the product applied for conforms to the national standards and industry standards, a statement that the production enterprise assumes the quality responsibility after the product is listed, and a description of the product model and specification division.

"Signature" here refers to the seal of the enterprise, or the signature of its legal representative and responsible person plus the seal of the enterprise (hereinafter referred to as domestic medical devices, synonymous);

(four) product performance test report;

(5) A description of the existing resource conditions and quality management capabilities (including testing methods) of the products produced by the enterprise;

(6) Instructions for medical devices;

(7) Self-assurance statement on the authenticity of the submitted materials: it shall include the list of submitted materials and the commitment of the production enterprise to bear legal responsibilities.

3, technical supervision bureau to apply for testing