A class of medical devices for the record the materials required are: 1, a copy of the business license of the enterprise, a copy of the organization code certificate; 2, legal person ID card, production, quality management personnel education certificate; 3, the main production equipment and testing devices, product risk analysis information, safety risk analysis report; 4, product technical requirements, products in line with national industry standards List, product testing reports, clinical evaluation information, product manuals and labels, production and manufacturing information.
Legal objective:According to China's "supervision and management of medical devices regulations", Article 9 provides that: the first class of medical device products for the record and apply for registration of the second and third class of medical device products, the following information should be submitted: (a) product risk analysis information; (b) product technical requirements; (c) product test reports; (d) clinical evaluation information; (e) product specifications and labeling samples; (F) and product development, production and quality management system documents; (G) to prove that the product is safe, effective and other information required. Applicants for registration of medical devices, the record shall be responsible for the authenticity of the information submitted.