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

• Published in: Zhongguo 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
• Language: Chinese
• Published: China 30.05.2023
• Subjects: clinical evaluation; equivalence demonstration; medical device

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...