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KMID : 1137820220430030153
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의공학회지
2022 Volume.43 No. 3 p.153 ~ p.160
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A Comparative Study on Innovative Medical Device Management Systems in Major Countries
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Lee Jin-Su
Lee Jin-Su
Kim Su-Kyeong
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Abstract
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As new types of medical devices are emerging through convergence with advanced technology, innovative technologies are becoming hot issues in health policy because of their disruptiveness. This study analyzed the inno- vative medical device management systems in the US, China and Korea. Innovative medical devices have been defined differently depending on the country’s management system, but in common, they are defined as products that do not exist or have dramatically improved performance compare to existing products by applying innovative technologies. Innovative medical devices have been supported by regulatory authorities during product development and approval processes. While the US and China have more than 300 products designated as innovative medical devices with diverse functions, application fields, and manufacturing countries considering the initial situation of the implementation for the system, Korea has only 16 products, mainly radiology and diagnostic devices and made in Korea only as innovative medical device. In addition, Korea shows the highest market approval rate of innovative medical devices compare to the US and China, and it is necessary to prepare the approval process in consideration of product diversity.
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KEYWORD
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innovative medical device, management system, approval process, product diversity
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