Requirements for Evaluation on Drug-medical Device Requirements for Evaluation on Drug-medical Device

Requirements for Evaluation on Drug-medical Device

  • 期刊名字:中国生物医学工程学报(英文版)
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  • 论文作者:DENG Jie,TIAN Jia-xin,GU Han-q
  • 作者单位:Center for Medical Device Evaluation,Tianjin Medical University
  • 更新时间:2023-04-16
  • 下载次数:
论文简介

The administration of combination products in U.S.Food and Drug Administration (FDA) are analyzed and summarized in this paper. Furthermore, the technical evaluation on drug-medical device in the State Food and Drug Administration of China (SFDA) is also illustrated. Meanwhile,this paper discusses how to promote the development of drug-medical device in the administration and technical evaluation.

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