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KMID : 1142220150100010075
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Regulatory Research on Food, Drug & Cosmetic
2015 Volume.10 No. 1 p.75 ~ p.82
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A Study on the Approval of In Vitro Diagnostic Products as Medical Devices
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Lee Won-Kyu
Kim Su-Young
Kim Jung-Hwan
Ahn Young-Wook
Kim Hyun-Joon
Woo Seung-Min
Jeong Hee-Kyo
Oh Hyeon-Joo
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Abstract
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The in vitro diagnostics (IVD) sector will be the largest medtech segment in 2018 due to the change of desease management paradigm from treatment to prevention by early diagnosis, according to a recent UN report. IVD products are those reagents, instruments, and systems intended for use in diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, or prevent disease or its sequelae. Ministry of Food and Drug Safety (MFDS) classifies IVD products into Class I~IV according to the level of regulatory control that is necessary to a assure safety and effectiveness. For Class I devices list Pre-Market Notification application including basic device informations to regional Food and Drug Administration, and for Class II~IV devices submit general technical files or safety & effectiveness technical files to National Institute of Food and Drug Safety Evaluation for approval, respectively.
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KEYWORD
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In vitro diagnostic device, Ministry of Food and Drug Safety, National Institute of Food and Drug Safety Evaluation, Medical device act
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FullTexts / Linksout information
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Listed journal information
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