(a) medical device registration application form;
(b) proof of qualification of medical device manufacturers: including the manufacturer's license, a copy of the business license; the declared products should be within the scope of the license approval of the production;
(c) the product technical report; at least should include the technical specifications or the main performance Requirements for the determination of the basis of content;
(d) safety risk management report; in accordance with the requirements of YY0316 "medical device risk management" standard preparation. There should be energy hazards, biological hazards, environmental hazards, hazards related to the use of hazards and functional failure, poor maintenance and aging caused by the hazards of five aspects of the analysis and the corresponding preventive measures.
(E) national standards, industry standards or registered product standards and instructions; the use of national standards, industry standards as the applicable standards of the product, the product should be provided to comply with national standards, industry standards, and bear the responsibility for the quality of the products listed on the statement and the relevant product models, specifications and division of the description, the national standards adopted by the submission of the national standards or industry standards of the text. Registered product standards should be commissioned by the manufacturer or producer to draft standards for the unit signed. Production enterprises commissioned to draft standards should be noted in the commission "product quality by the manufacturer is responsible for".
(F) product performance self-test report; product performance self-test project for the registered product standards in the factory testing program, there should be the main inspection, audit signature. If the enterprise implementation of national standards and industry standards, should be supplemented with self-defined factory test items.
(VII) State Food and Drug Administration recognized medical device testing organizations issued by the product registration test report; the need for clinical trials of medical devices, clinical trials should be submitted to the start of the six months prior to the issuance of the test report. Do not need to conduct clinical trials of medical devices, should be submitted to the registration acceptance within one year before the issuance of the test report. Implementation of the provisions of Article 11, Article 12, Article 13, Article 14, shall provide the appropriate documents.
(viii) more than two clinical trial sites of clinical trial information;
(ix) product instruction manual;
(x) product production quality system assessment (certification) of valid documents.