可降解镁金属骨科植入器械简介及注册审评考量
Orthopaedic Biomechanics Materials and Clinical Study（2023）
Abstract
可降解镁金属骨科植入器械在骨修复重建功能过程中,能够逐渐被机体代谢吸收,具有广阔的应用前景.本文对可降解镁金属骨科植入器械进行简要介绍,针对该类器械应用的风险点,整理注册审评过程中的关注点,并对该类产品注册审评中医疗器械补正资料通知的具体内容进行讨论和提出解决方案,为产品研发转化提供支持.
MoreKey words
Degradable,Magnesium,Orthopedic implant materials,Registration evaluation
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