组织工程类医疗器械监管概述及技术审评考量  

Overview and Technical Review of Tissue Engineering Medical Devices

作　　者：刘钰莎 李青 LIU Yusha;LI Qing(Center for Medical Device Evaluation of NMPA,Beijing 100076,China;Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA,Shanghai 201210,China)

机构地区：[1]国家药品监督管理局医疗器械技术审评中心,北京100076 [2]国家药品监督管理局医疗器械技术审评检查长三角分中心,上海201210

出　　处：《中国医药导刊》2025年第1期94-100,共7页Chinese Journal of Medicinal Guide

基　　金：国家重点研发计划“组织工程类医疗器械产品安全性有效性评价技术研究”项目(2022YFC2409800);软组织缺损修复组织工程医疗器械产品评价技术研究课题(2022YFC2409801)。

摘　　要：组织工程类医疗器械是具有前景的前沿科技产业,受到了全球各个国家和地区的战略重视和投入,目前,国内外已有一些特定类型的组织工程医疗产品(TEMPs)上市,但该类产品的多样性和复杂性也为监管带来了巨大挑战。本研究列举了组织工程类医疗器械在《医疗器械分类目录》中可能涉及的产品分类,汇总了国内已上市的产品类型,包括已批准的含活细胞的组织工程产品、含生物活性因子产品、脱细胞支架产品、其他高分子聚合物制成的组织工程支架产品等,概述了TEMPs在国际上的监管策略,开展了与国内监管模式的比较,建议我国可以建立专门的组织工程产品委员会或办公室,为推进该领域产业化发展提供进一步支撑。同时,结合中国药品监管科学行动计划、国家重点研发计划的研究项目,本研究总结了组织工程类医疗器械的监管科学研究进展;根据组织工程类医疗器械的产品特性和应用场景,本研究提出了该类产品在技术审评中需要额外关注的要点,旨在为适应组织工程科学的高速发展、组织工程类医疗器械产业的迅速壮大,对该类产品的监管需要不断探索创新,紧跟前沿发展动态,及时研究并构建科学的评价方法和体系。Tissue engineering medical devices are a promising frontier science and technology industry,which has received strategic attention and investment from various countries and regions in the world.At present,some specific types of tissue engineering medical products(TEMPs)have been listed at home and abroad,but the diversity and complexity of such products have also brought great chal-lenges to regulation.This study lists the possible product categories of tissue engineering medical devices in the medical device classifica-tion catalogue,and summarizes the types of products that have been listed in China,including approved tissue engineering products con-taining living cells,products containing bioactive factors,acellular scaffolds,and tissue engineering scaffolds made of other polymers.This study summarizes the supervision strategy of TEMPs in the world,and compares it with the domestic supervision model.It is sug-gested that China can establish a special committee or office of tissue engineering products to provide further support for promoting the industrialization of this field.Combined with the research projects of China Drug Regulatory Science Action Plan and National Key Research and Development Plan,this study presents the research progress of regulatory science of tissue engineering medical devices.According to the product characteristics and application scenarios of tissue engineering medical devices,this study puts forward the key points that need extra attention in the technical evaluation of this kind of products in order to adapt to the rapid development of tissue engi-neering science and the rapid growth of the tissue engineering medical device industry,the supervision of such products needs to con-stantly explore and innovate,keep up with the cutting-edge development trends,and timely study and build scientific evaluation methods and systems.

关 键 词：组织工程 医疗器械 监管科学 技术审评 

分 类 号：R95[医药卫生—药学] F203[经济管理—国民经济]