Application materials: (a) application form for registration of medical devices;
(2) 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 approved the production;
(3) the product technical report; at least should include the technical indicators or the main performance requirements of the determination of the basis of the content;
(d) safety risk management report;
(e) national standards, industry standards or registered product standards and instructions; the adoption of national standards, industry standards as the applicable standards of the product, should provide the applied for products in line with national standards, industry standards, and bear the responsibility for the quality of the product on the market after the statement of the quality of the statement and the relevant product models, specifications and classification of the description of the national standards adopted or the text of the industry standards. The text of the adopted national standards or industry standards.
(F) product performance self-test report; product performance self-test project for the registration of product standards for factory testing projects, there should be the main inspection, the auditor's signature.
(VII) State Food and Drug Administration accredited 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.
(viii) more than two clinical trial base clinical trial information;
(ix) product instructions;
(x) product quality system assessment (certification) of the validity of the documents.