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KMID : 1137820180390060268
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의공학회지
2018 Volume.39 No. 6 p.268 ~ p.277
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A Study on Classification and Differential Grade Management for Medical Devices
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Lim Kyeong-Min
Song Tong-Jin
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Abstract
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With drastic change in the market and technology of medical devices, a comparative analysis is necessary in advanced systems internationally in order to prepare domestically applicable plans for improvement in classification and differential grade management for items of medical devices. This research examines and analyzes the differences of definition and legal systems of medical devices among Korea, United States, EU, Japan and China, and investigates classification and grading system of each country to identify disadvantages of classification and grading structures for medical device in Korea. This research suggests ways to supplement the disadvantages of domestic classification and grading system of medical devices, and elicits differential management plans for medical devices.
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KEYWORD
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Medical device, Classification, Grade, Safety, Management
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