(1) "Medical Device Manufacturer License" (start-up) application form;
(2) legal representative, the basic situation of the person in charge of the enterprise 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) 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. 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 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. List the directory of application materials, and the materials to make a commitment to bear legal responsibility if false. (2) Secondly, your product needs to have a class of 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: the adoption of national standards, industry standards as the applicable standards for the product, the Should be submitted to the adopted national standards, industry standards of the text; registered product standards should be signed by the manufacturer. Producers should provide the application for products in line with national standards, industry standards, the statement that the manufacturer assumes responsibility for the quality of the products listed on the statement as well as the relevant product models, specifications and 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);
Legal basis:
"Supervision and Administration of Medical Devices Regulations"
"Article 4 of the State Medical Devices Supervision and Administration of Medical Devices Regulations"
Article 4 of the State Medical Devices Supervision and Administration of Medical Devices Regulations. p>Article 4 of the state of medical devices in accordance with the degree of risk to implement classification management.
The first category is a low degree of risk, the implementation of routine management can ensure the safety and effectiveness of medical devices.
The second category is a moderate risk, need to strictly control the management to ensure the safety and effectiveness of medical devices.
The third category is a high risk, need to take special measures to strictly control the management to ensure the safety and effectiveness of medical devices.
Evaluating the degree of risk of medical devices should take into account the intended purpose of the medical device, structural features, use and other factors.
The food and drug administration department under the state council is responsible for formulating the classification rules and classification directory of medical devices, and analyzing and evaluating the risk changes of medical devices in a timely manner according to the production, operation and use of medical devices, and adjusting the classification directory. The formulation and adjustment of the classification directory shall fully listen to the opinions of the medical device production and operation enterprises as well as the use of units, industry organizations, and refer to the international medical device classification practice. Classification of medical devices catalog should be published to the community.