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可吸收运动医学植入物应用进展及同品种比对路径临床评价技术审评关键点
Application progress of absorbable sports medicine implants and the technical review key points of clinical evaluation by the same variety comparison path
投稿时间:2023-09-05  
DOI:10.3969/j.issn.1672-5972.2024.03.016
中文关键词:  可吸收  运动医学  临床评价
英文关键词:Absorbable  Sports medicine  Clinical evaluation
基金项目:国家重点研发计划(2018YFB1105600)
作者单位邮编
程玮璐 国家药品监督管理局医疗器械技术审评中心北京100081 100081
张译丹 国家药品监督管理局医疗器械技术审评检查大湾区分中心深圳518045 518045
滕颖影 国家药品监督管理局医疗器械技术审评中心北京100081 100081
蒋研 国家药品监督管理局医疗器械技术审评中心北京100081 100081
刘英慧 国家药品监督管理局医疗器械技术审评中心北京100081 100081
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中文摘要:
      可吸收运动医学产品在运动损伤修复后能够逐渐被机体代谢吸收,相较于不可吸收产品,具有广阔的应用前景,但其同品种临床评价的具体要求并不明确,本文对可吸收运动医学产品进行概述,结合部分成熟产品(如可吸收带线锚钉、可吸收界面螺钉)临床评价审评过程中的侧重点,整理需重点关注内容。为后续该类产品注册申报时的临床评价提供指导,帮助申请人更高效地准备注册申报资料。
英文摘要:
      Absorbable sports medicine products can be gradually absorbed by the body after sports injury repair, avoiding the risk of foreign body reaction caused by the long-term existence of non-absorbable products, which has broad application prospects and attracts much market attention. In order to clarify the specific requirements of clinical evaluation which though comparison with predicate medical device and promote the successful registration of such products, this paper summarizes the absorbable sports medicine products and combines the emphasis in the clinical evaluation review process of some mature products (such as absorbable thread anchor, absorbable interface screw), refining the focus of clinical evaluation of the same species, to assist enterprises in design and development, guide regulatory agencies in technical review, and ensure the safety and efficacy of the declared product.
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