표 1. 국내 의료기기 등급분류 Table 1. Medical device classification in Republic of Korea
표 2. 국내 체외 진단용 의료기기 등급 분류 Table 2. IVD medical device classification in Republic of Korea
표 3. 미국 의료기기의 등급 분류 Table 3. Medical device classification in US
표 4. 유럽연합의 의료기기 최상위 분류 Table 4. Top classification of Medical devices for individual rules
표 5. 유럽연합의 의료기기 등급 분류 Table 5. Medical device classification in EU
표 6. 일본의 의료기기 등급 분류 Table 6. Medical device classification in Japan
표 7. 중국의 의료기기 등급 분류 Table 7. Medical device classification in China
표 8. 중국의 의료기기 등급 분류 Table 8. Determination of medical device classification in China
표 9. 우리나라의 의료기기 대분류 체계 Table 9. Medical device category in Republic of Korea
표 10. 미국의 의료기기 대분류 체계 Table 10. Medical device category in US
표 11. 유럽연합의 의료기기 대분류 Table 11. Medical device category in EU
표 12. 일본의 의료기기 대분류 Table 12. Medical device category in Japan
표 13. 중국의 의료기기 대분류 Table 13. Medical device category in China
참고문헌
- C.H. Park, The Comparative Legal Research on the Safety System of Food and Drug Administration, Seoul, Korea: Ministry of Food and Drug Safety, 2009, pp. 40-42.
- K.M. Lee, A study on the new medical devices(medical supplies) assortment system, Seoul, Korea: Ministry of Food and Drug Safety, 2009, pp. 1-342.
- K.M. Lee, A study on the new medical devices(Medical instruments) assortment system, Chungbuk, Korea: Ministry of Food and Drug Safety, 2010, pp. 1-61.
- K.M. Kim, The study on the establishment of the classification system of medical devices(dental materials), Chungbuk, Korea: Ministry of Food and Drug Safety, 2011, pp. 1-40.
- Y. Kim, A study to re-define and re-classify medical devices under the category of Devices for Physical Treatments, Chungbuk, Korea: Ministry of Food and Drug Safety, 2015, pp. 1-306.
- Y.W. Kim, C.M. Shin, and K.J. Park, et al., "Preparation of guidance documents item by item for one-step evaluation and approval for Medical Devices," J. Biomed. Eng. Res., vol. 31, no. 4, pp. 280-284, 2010.
- K.J. Park, G.H. Ryu, and S.H. Lee, et al., "The Development for guideline of raw matrials on technical document of Medical Device," J. Biomed. Eng. Res., vol. 31, no. 6, pp. 434-437, 2010.
- http://www.mfds.go.kr/index.do, accessed on Jul. 29, 2016.
- Medical Device Act.
- Enforcement Decree of the Medical Device Act.
- Enforcement Regulations of the Medical Device Act.
- Ministry of Food and Drug Safety Notification No. 2016-79.
- http://www.fda.gov, accessed on Jul. 29, 2016.
- 21 USC, Section 321-399.
- 21 CFR, Part 800-1299.
- http://ec.europa.eu/growth/sectors/medical-devices, accessed on Jul. 29, 2016.
- Medical Device Directive 93/42/EEC.
- Active Implantable Medical Devices 90/385/EEC.
- In Vitro Diagnostic Medical Device Directive 98/79/EC.
- Directive 2007/47/EC.
- http://www.mhlw.go.jp, accessed on Jul. 29, 2016.
- Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
- Order for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
- Regulation for Enforcement of the Act on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices.
- Pharmaceutical and Food Safety Bureau Notice No. 0720022.
- http://www.sfda.gov.cn, accessed on Jul. 29, 2016.
- Decree of the State Council of the People's Republic of China. No. 650.