A class of medical devices can be produced after the record

A class of medical devices for the record the materials required are: a copy of the business license of the enterprise, a copy of the copy of the organization code certificate, the legal person ID card, production, quality management personnel academic certificates, the main production equipment and testing devices, product risk analysis information, safety risk analysis report, product technical requirements, the product in line with 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 specifications and labeling samples; (f) the product specification and labeling samples; (g) the product specification and labeling samples; (h) the product specification and labeling samples. (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.