Journal of Biomedical Engineering Research (대한의용생체공학회:의공학회지)

The Korean Society of Medical and Biological Engineering (대한의용생체공학회)
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A Study on Classification and Differential Grade Management for Medical Devices

의료기기 품목 재분류 및 차등 관리방안 연구

  • Lim, Kyeongmin (Department of Biomedical Engineering, Jungwon University) ;
  • Song, Tongjin (Department of Biomedical Engineering, Jungwon University)
  • 임경민 (중원대학교 생체의공학과) ;
  • 송동진 (중원대학교 생체의공학과)
  • Received : 2018.12.03
  • Accepted : 2018.12.12
  • Published : 2018.12.31
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Abstract

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.

Keywords

표 1. 국내 의료기기 등급분류 Table 1. Medical device classification in Republic of Korea

OOSCB@_2018_v39n6_268_t0001.png 이미지

표 2. 국내 체외 진단용 의료기기 등급 분류 Table 2. IVD medical device classification in Republic of Korea

OOSCB@_2018_v39n6_268_t0002.png 이미지

표 3. 미국 의료기기의 등급 분류 Table 3. Medical device classification in US

OOSCB@_2018_v39n6_268_t0003.png 이미지

표 4. 유럽연합의 의료기기 최상위 분류 Table 4. Top classification of Medical devices for individual rules

OOSCB@_2018_v39n6_268_t0004.png 이미지

표 5. 유럽연합의 의료기기 등급 분류 Table 5. Medical device classification in EU

OOSCB@_2018_v39n6_268_t0005.png 이미지

표 6. 일본의 의료기기 등급 분류 Table 6. Medical device classification in Japan

OOSCB@_2018_v39n6_268_t0006.png 이미지

표 7. 중국의 의료기기 등급 분류 Table 7. Medical device classification in China

OOSCB@_2018_v39n6_268_t0007.png 이미지

표 8. 중국의 의료기기 등급 분류 Table 8. Determination of medical device classification in China

OOSCB@_2018_v39n6_268_t0008.png 이미지

표 9. 우리나라의 의료기기 대분류 체계 Table 9. Medical device category in Republic of Korea

OOSCB@_2018_v39n6_268_t0009.png 이미지

표 10. 미국의 의료기기 대분류 체계 Table 10. Medical device category in US

OOSCB@_2018_v39n6_268_t0010.png 이미지

표 11. 유럽연합의 의료기기 대분류 Table 11. Medical device category in EU

OOSCB@_2018_v39n6_268_t0011.png 이미지

표 12. 일본의 의료기기 대분류 Table 12. Medical device category in Japan

OOSCB@_2018_v39n6_268_t0012.png 이미지

표 13. 중국의 의료기기 대분류 Table 13. Medical device category in China

OOSCB@_2018_v39n6_268_t0013.png 이미지

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