주요국의 의료기기 본질적 동등성 판단기준 분석 및 국내 의료기기 본질적 동등성 판단 절차 마련 연구
A Study on the Analysis of Substantial Equivalence Criteria for Medical Devices in Major Countries and the Development of a Determination Procedure in Korea
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This study aims to establish a determination procedure for substantial equivalence of medical devices in Korea. In Korea, substantial equivalence is evaluated by comparing the intended use, mechanism of operation, raw materials, performance, test standards, and instructions for use. In the United States, substantial equivalence is demonstrated based on intended use and technical characteristics. In Europe, substantial equivalence is determined by considering technical, biological, and clinical characteristics. In this study, a procedure and flowchart were devel- oped based on Korea’s substantial equivalence determination criteria for medical devices. The proposed procedure is expected to assist manufacturers aiming for medical device approval and certification to determine the substantial equivalence of medical devices and clearly define the scope of documentation required for submission
Abstract
This study aims to establish a determination procedure for substantial equivalence of medical devices in Korea. In Korea, substantial equivalence is evaluated by comparing the intended use, mechanism of operation, raw materials, performance, test standards, and instructions for use. In the United States, substantial equivalence is demonstrated based on intended use and technical characteristics. In Europe, substantial equivalence is determined by considering technical, biological, and clinical characteristics. In this study, a procedure and flowchart were devel- oped based on Korea’s substantial equivalence determination criteria for medical devices. The proposed procedure is expected to assist manufacturers aiming for medical device approval and certification to determine the substantial equivalence of medical devices and clearly define the scope of documentation required for submission