What materials do I need to submit to apply for the registration of Class III medical devices?

A: According to the provisions of the Administrative Measures for the Registration of Medical Devices and the Administrative Measures for the Registration of in vitro Diagnostic Reagents issued on February 5, 20 15. The materials required to apply for the registration of Class III medical devices include:

Application form, certification documents, list of basic requirements for safety and effectiveness of medical devices, review materials, research materials, production information, clinical evaluation materials, product risk analysis materials, product technical requirements, product registration inspection report, sample instructions and labels, conformity statement and other materials.