The first class of medical devices need to be submitted for the record safety risk analysis report, product technical requirements, product testing reports, clinical evaluation information, product specifications and the minimum sales unit labeling design samples, production and manufacturing information, supporting documents, declaration of conformity and other information.
Application for registration of medical devices need to submit the following information:
Application for registration of medical devices need to submit the application form, supporting documents, the list of basic requirements for the safety and efficacy of medical devices, overview information, research information, manufacturing information, clinical evaluation information, product risk analysis information, product technical requirements, product registration and inspection reports, manuals and labels, declaration of conformity. The company's website has been updated with the latest information on the company's website.