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KMID : 0986720220300010025
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Korean Journal of Medicine and Law
2022 Volume.30 No. 1 p.25 ~ p.46
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Clinical research for robotic medical devices and legal challenges
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Kim Ki-Young
Huh Jung-Sik
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Abstract
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Robotic surgery may open new avenues of surgical operation in the future. The size of the global surgical robot market is also expected to increase through the development of medical devices that have improved or are expected to improve safety and effectiveness compared to existing medical devices or treatments by applying advanced technology. However, development of robotic medical devices requires high-level evaluation along with special training and experience. In order to prevent the side effects of robotic surgery in advance, the safety and reliability of these medical devices, providing appropriate information, and maintaining confidentiality are all most important.
In this study, the types and status of robotic medical devices and the necessity and types of clinical research on medical devices are reviewed, and major issues regarding the legal framework for clinical trials of robotic medical devices are reviewed. As an exception to clinical trials under the Medical Device Act, the legal limits of the legal framework for post-marketing research are reviewed and conclusions are drawn on the legal regulations for robotic medical devices.
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KEYWORD
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Robot, Robotic surgery, Medical Device, clinical trial, AI
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