국내 의료기기관리제도의 현황분석에 따른 정책적 제도개선 방안에 관한 연구


A study on the system improvement policy according to the status analysis of medical device control system in Korea

이경만, 백낙기, 서종현

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This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).


 1. 서론
  1.1 연구의 필요성
  1.2 연구의 목적
 2. 의료기기관리제도 현황 및 분석
  2.1 의료기기관리제도에 대한 기본구조
  2.2 국내·외 의료기기관리제도 현황
 3. 연구 분석모형 및 정책 추진방향
  3.1 의료기기관리제도의 개선 모형
  3.2 의료기기관리제도 설문조사 실증분석
  3.3 제도선진화를 위한 정책 추진방향
 4. 결론
  4.1 연구결과
  4.2 연구의 한계 및 향후 연구방향
 5. 참고문헌


  • 이경만 Kyung-Man Lee. 한국산업기술시험원
  • 백낙기 Nak-Ki Baek. 한국산업기술대학교
  • 서종현 Jong-Hyun Seo. 한국산업기술대학교


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