(a) the domestic medical device registration application form;
(b) medical device manufacturer qualification certificate: including the manufacturer's license, a copy of the business license, and the product should be applied for in the manufacturer's license within the scope of the approved production;
(c) the product technical report: At least should include technical indicators or the main performance requirements for determining the basis of content;
(d) safety risk analysis report: in accordance with YY0316 "medical device risk analysis" standard requirements. There should be energy hazards, biological hazards, environmental hazards, hazards related to the use of hazards and by the failure of function, poor maintenance and aging caused by the hazards of the five aspects of the analysis and the corresponding preventive measures;
(E) the applicable product standards and instructions: the use of national standards, industry standards as the applicable standards of the product should be submitted to the national standards adopted by the national standards, industry standards of the text; registration Product standards should be signed by the manufacturer.
Producers should provide the application of the product in line with national standards, industry standards, the statement of the manufacturer to assume responsibility for the quality of the product on the market, as well as the relevant product model, specification division of the description;
(F) product performance self-test report: product performance self-test project for the registration of the product standard for the factory testing program, there should be a principal inspector or the person in charge of the main inspection, Auditor signature.
The implementation of national standards, industry standards, manufacturers should supplement the self-defined factory test items;
(VII) medical device testing organizations issued by the product registration test report: the need for clinical trials of medical devices, should be submitted to the clinical trials within six months prior to the start of the test report issued by the medical device testing organization. Do not need to conduct clinical trials of medical devices, should be submitted to the registration acceptance within one year before the test report issued by the medical device testing organization. Implementation of the provisions of Article 11, Article 12, Article 13, Article 14 of these Measures, should provide the corresponding description of the document;
(h) medical device clinical trial information;
(ix) medical device instruction manual;
(j) product production quality system assessment (certification) of the validity of the supporting documents -According to the requirements of different products, provide the appropriate quality system assessment report: 1, provinces, autonomous regions, municipalities directly under the Central (Food) Drug Administration signed within the validity period of the system assessment report; 2, medical device production quality management standard inspection report or medical device quality system certification; 3, the state has implemented the implementation of the production of implementation rules, submit the Implementing rules for the inspection and acceptance report;
(k) the authenticity of the materials submitted by the self-assurance statement: should include a list of materials submitted, the production of enterprises to assume legal responsibility for the commitment
.