监督管理

胶原蛋白类医疗器械产业发展及监管现状

  • 祝洁 ,
  • 朱嘉慧 ,
  • 刘尧
展开
  • 深圳市医疗器械检测中心,深圳 518000
祝洁 Tel:(0755)86713727;E-mail:jeazhu@qq.com
刘尧 Tel:(0755)86713478;E-mail:Yxliuyao@126.com

收稿日期: 2024-10-01

  网络出版日期: 2025-05-27

基金资助

广东省药品监督管理局 2023年科技创新项目(编号2023TDB40); 广东省药品监督管理局2022 年科技创新项目(编号2022TDB53); 深圳市药品检验研究院十大科研课题(编号YNKT20230106)

Development and Regulatory Status of Collagen-Based Medical Device Industry

  • Zhu Jie ,
  • Zhu Jiahui ,
  • Liu Yao
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  • Shenzhen Testing Center of Medical Device, Shenzhen 518000, China

Received date: 2024-10-01

  Online published: 2025-05-27

摘要

目的: 分析热门医疗器械材料胶原蛋白的基本知识、产品应用及监管政策,为胶原蛋白类医疗器械的研发、生产与上市提供参考。方法: 通过文献检索,分析胶原蛋白信息与产业形势;梳理胶原蛋白类医疗器械的获证情况,分析产业的发展方向与趋势;梳理相关标准与政策文件,探讨监管要点。结果与结论: 共检索出70篇相关文献,梳理国内取证胶原蛋白类医疗器械1009个,涉及指导原则、监管政策文件和标准25个。全球胶原蛋白类医疗器械发展已有140多年,因具有优异的生物相容性和功能性,其在创面治疗、组织修复与再生以及医美植入等领域被广泛应用,呈现动物源和重组两类胶原蛋白相互补充的市场状况。我国监管与时俱进,推出了多项胶原蛋白类监管的标准与技术评审原则,为胶原蛋白类医疗器械产业健康规范发展提供保障。

本文引用格式

祝洁 , 朱嘉慧 , 刘尧 . 胶原蛋白类医疗器械产业发展及监管现状[J]. 中国药事, 2025 , 39(3) : 306 -316 . DOI: 10.16153/j.1002-7777.2024-10-0002

Abstract

Objective: To research and analyze the basic knowledge, product application and regulatory policy of collagen, a popular medical device material, in order to provide references for the research and development, production and marketing of collagen-based medical devices. Methods: Literature search was conducted to understand the information and industrial situation of collagen. The licensed status of collagen-based medical devices were sorted out and the development direction and trend of the industry were analyzed. The relevant standards and policy documents were sorted out to grasp the key points of regulation. Results and Conclusion: With reference to 70 relevant literatures, 1009 collagen-based medical devices have been licensed in China, involving guidelines, regulatory documents and standards, which were a total of 25. Collagen-based medical devices have been developed for more than 140 years globally, and are widely used in the fields of wound treatment, tissue repair and regeneration, and medical aesthetic implantation due to their excellent biocompatibility and functionality. The market presents two types of collagen, animal source and recombinant, which complement each other. Domestic regulation is advancing with the times, and a number of collagen-based regulatory standards and technical review principles have been introduced to provide protection for the healthy and standardized development of the collagen-based medical device industry.

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