Dentures are medical devices.
(a) Application form for registration of medical devices within the territory.
(ii) medical device manufacturer's qualification certificate: including the manufacturer's license, a copy of the business license, and the product applied for should be in the manufacturer's license approved within the scope of production.
(C) product technical reports: at least should include technical indicators or the main performance requirements to determine 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 product standards 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 of the product 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 model, specifications division of the description.
(F) product performance self-test report: product performance self-test project for the registration of product standards for factory testing projects, there should be a principal inspector or the person in charge of the main inspection, the auditor's signature. Implementation of national standards, industry standards, the manufacturer shall 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 trial within six months before the start of the test report issued by the medical device testing organizations. 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.
The 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 instructions.
(J) product production quality system assessment (certification) of effective documents - according to the requirements for different products, provide the corresponding quality system assessment report.