국내 의료기기 임상시험 자료 제출 대상 판단을 위한 체계적 절차에 관한 연구

Abstract

In Korea, the submission of clinical evidence is required as supporting evidence to demonstrate the safety and effectiveness of medical devices. This study proposes a procedure for determining whether medical devices require clinical evidence submission, aiming to assist manufacturers in assessing its necessity. The criteria for deter- mination of medical devices for clinical evidence submission in Korea were established through an investigation of relevant regulations. A category reflecting detailed determination criteria was established, flowchart was proposed to determine the subjects for clinical evidence submission. The proposed procedure in this study is expected to deter- mine the subject of submission of clinical evidence systematic and clearly, for manufacturing, import, approval, and certification medical devices to determine clinical evidence submission requirements.