Analysis of Revision Content and Evaluation Attentions on Guidance for Registration of Metallic Bone Plate Internal Fixation System (Revised in 2021) / 中国医疗器械杂志

ABSTRACT

This study briefly introduces the revised content of Guidance for Registration of Metallic Bone Plate Internal Fixation System (Revised in 2021) compared to the original guidance, mainly including the principles of dividing registration unit, main performance indicators of standard specification, physical and mechanical performance research, and clinical evaluation. At the same time, in order to provide some references for the registration of metallic bone plate internal fixation system, this study analyzes the main concerns in the review process of these products based on the accumulation of experience combining with the current review requirements.