1, domestic medical device registration application form;
2. Qualification certificate of medical device manufacturing enterprise: including a copy of the license and business license of the manufacturing enterprise, and the products applied for shall be within the production scope approved by the license of the manufacturing enterprise;
3. Product technical report: at least include technical indicators or the basis for determining main performance requirements;
4. Safety risk analysis report: prepared according to the requirements of YY03 16 Risk Analysis of Medical Devices. There should be an analysis of energy hazards, biological hazards, environmental hazards, related use hazards and hazards caused by functional failure, poor maintenance and aging, as well as corresponding preventive measures;
5. Applicable product standards and descriptions: If national standards and industry standards are adopted as applicable standards for products, the texts of the adopted national standards and industry standards shall be submitted; The registered product standard shall be signed and sealed by the production enterprise. The production enterprise shall provide a statement that the product applied for conforms to the national standards and industry standards, a statement that the production enterprise bears the quality responsibility after the product goes on the market, and a description of the division of product models and specifications;
6. Product performance self-inspection report: The product performance self-inspection items are the ex-factory inspection items specified in the registered product standards, and shall be signed by the chief inspector or the chief inspector and auditor. Where national standards and industry standards are implemented, the production enterprise shall supplement the customized ex-factory inspection items;
7. Product registration test report issued by medical device testing institutions: For medical devices that need clinical trials, the test report issued by medical device testing institutions within six months before the start of clinical trials shall be submitted. For medical devices that do not need clinical trials, the test report issued by the medical device testing institution within 1 year before registration acceptance shall be submitted. Where the provisions of Articles 11, 12, 13 and 14 of these Measures are implemented, the corresponding explanatory documents shall be provided;
8. Clinical trial data of medical devices;
9. Instructions for medical devices;
10, valid certification documents of product quality system review (certification)-provide corresponding quality system review reports according to the requirements of different products.
Legal basis: Article 13 of the Regulations on the Supervision and Administration of Medical Devices.
The first category of medical devices shall be subject to product filing management, and the second and third categories of medical devices shall be subject to product registration management.
Medical device registrants and filers should strengthen the quality management of medical devices in the whole life cycle, and be responsible for the safety and effectiveness of the whole process of research and development, production, management and use of medical devices according to law.