| 可降解镁金属骨科植入器械简介及注册审评考量 |
| Introduction and registration evaluation concerns of degradable magnesium-based orthopedic implants |
| 投稿时间：2022-07-04 |
| DOI：10.3969/j.issn.1672-5972.2023.04.001 |
| 中文关键词: 可降解 镁金属 骨科植入材料 注册审评 |
| 英文关键词:Degradable Magnesium Orthopedic implant materials Registration evaluation |
| 基金项目:科技部十三五重点研发计划（No. 2108YFC1106700） |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| Degradable magnesium-based orthopedic implants can be gradually absorbed by the body in the process of bone repair and reconstruction, which have broad application prospects. This paper gives a brief introduction of degradable magnesium-based orthopedic implant materials, and reviews the concerns of such materials in the registration and evaluation process for the application risk. The specific problems in the notification of supplementary information are discussed and solutions are proposed to provide support for product research and transformation. |
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