Cancel a class of medical devices for the record

The materials required for the filing of a class of medical devices 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.

According to China's "supervision and management of medical devices regulations" Article IX provides that: the first class of medical device products for the record and apply for registration of the second, third class of medical device products, should be submitted to the following information: (a) product risk analysis information; (b) product technical requirements; (c) product test reports; (d) clinical evaluation information; (e) product instructions and labeling samples; (f) product instructions and labels. (E) product specifications and labeling samples; (F) 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.