A Brief Analysis of Equivalence Demonstration Techniques for Clinical Evaluation of Medical Devices

This study overviewed equivalence demonstration, the principles for the selection of comparative devices, the difficulties in equivalence demonstration, and the equivalence demonstration of special medical devices. In addition, the concept of equivalence demonstration was adopted for the products ex...

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Published inZhongguo yi liao qi xie za zhi Vol. 47; no. 3; p. 328
Main Authors Tian, Huanhuan, Wu, Sujing, Liang, Yu, Wang, Weili, Ji, Chengxue
Format Journal Article
LanguageChinese
Published China 30.05.2023
Subjects
clinical evaluation
equivalence demonstration
medical device
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Summary:This study overviewed equivalence demonstration, the principles for the selection of comparative devices, the difficulties in equivalence demonstration, and the equivalence demonstration of special medical devices. In addition, the concept of equivalence demonstration was adopted for the products exempted from clinical evaluation, and there were many confusion in actual use. The operation points and difficult points of equivalence demonstration for the products exempted from clinical evaluation were introduced in order to provide reference for medical device colleagues.
Bibliography:ObjectType-Article-2
SourceType-Scholarly Journals-1
ObjectType-Feature-1
content type line 23
ISSN:1671-7104
DOI:10.3969/j.issn.1671-7104.2023.03.020