What information is needed for the record certificate of Class II medical devices

The materials required for the filing of a class I medical device are: a copy of the business license of the enterprise, a copy of the copy of the organization code certificate, legal person ID card, the production, quality management personnel education certificate, the main production equipment and testing devices, product risk analysis information, safety risk analysis report, product technical requirements, the product conforms to the list of national industry standards.

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 and third class of medical device products, the following information should be submitted: (a) the product risk analysis information; (b) the product technical requirements; (c) the product test report; (d) clinical evaluation information; (e) product instructions 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.