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KMID : 1142220180130010013
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Regulatory Research on Food, Drug & Cosmetic
2018 Volume.13 No. 1 p.13 ~ p.23
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Development of Guideline for the Pre-market Approval of Medical Device for Rehabilitation Robot in Korea
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Bae Young-Woo
Lee Chang-Hyung
Yang Se-Eun
Jung Ji-Yun
KIm Soo-Yeun
Kang Guen-Wo
Hong Choong-Man
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Abstract
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Worldwide, the industry of medical robot for rehabilitation (rehabilitation robot) has been highlighted, and a particular standard for it is being prepared by IEC. This guideline proposes the following three items to enhance the predictability of pre-market approval for the rehabilitation robot and to support the domestic manufacturers to preemptively possess technologies that can scientifically evaluate the basic safety and performance according to the international standard; 1) product classification of the rehabilitation robot 2) A method of segmentation for the rehabilitation robot according to their characteristics 3) basic safety and essential performance of the rehabilitation robot. First, we introduced the concept of degree of autonomy in accordance with IEC TR 60601- 4-1 to clearly define the product classification of the rehabilitation robots. In addition, the definition of the rehabilitation robot of IEC 80601-2-78(DIS) under development is additionally applied. Secondly, we proposed a method of segmentation for the rehabilitation robots so that manufacturers can establish proper risk management process. Finally, we introduced basic safeties according to IEC 80601-2-78(DIS), and essential performances which can be newly identified by the rehabilitation robot according to IEC TR 60601-4-1. The findings derived from the guideline are in harmony with the international standard (draft) and the international technical report. Those are also based on the opinions of experts from domestic companies, professional organizations and academia. The findings from the guideline will be of great help for product development and the pre-market approval of the rehabilitation robot. In addition, it is anticipated that it will be possible to reduce the time and economic costs into healthcare market by increasing the predictability of the pre-market approval of the rehabilitation robot. This will contribute to strengthening the competitiveness of the domestic medical device industry and to overseas exports by entering the early market.
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KEYWORD
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Medical Robot for Rehabilitation, Degree of Autonomy, Situation Awareness, Basic Safety, Essential Performance
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