4차 산업혁명의 핵심기술은 의료기기와 융합을 통해 새로운 개념의 의료기기 출시되면서 보건 산업의 변화를 가속화 하며 기존의 산업을 규정하는 영역이 점차 확대되고 있다. 특히 새로운 기술과 융합된 혁신적인 제품의 등장으로 기존 의료기기 규제는 산업의 급격한 변화에 대응하는데 한계를 보이고 있으며, 미국과 중국 등 주요국은 혁신적인 제품개발을 촉진하고 이를 활용하기 위한 정책을 추진하고 있다. 이에 본 연구에서는 국가별 의료 기기의 기존 분류체계와 새로운 의료기기 관리제도 및 제품 현황 등을 분석하였다.
제1장. 서론 ·························································································1
제1절 연구의 배경 및 목적 ····································································3
제2절 연구 내용 및 방법 ········································································4
제2장. 주요국의 의료기기 정의 및 분류체계 ·································7
제1절 미국 의료기기 정의 및 분류체계 ·················································9
제2절 유럽 의료기기 정의 및 분류체계 ···············································15
제3절 중국 의료기기 정의 및 분류체계 ···············································21
제4절 한국 의료기기 정의 및 분류체계 ···············································26
제5절 국가별 의료기기 분류체계 특징 분석 ·······································30
제3장. 국가별 새로운 의료기기 관리 현황 ··································37
제1절 미국 새로운 의료기기 관리 현황 ···············································39
제2절 중국 새로운 의료기기 관리 현황 ···············································47
제3절 한국 새로운 의료기기 관리 현황 ···············································54
제4절 국가별 새로운 의료기기 관리 현황 특징 분석 ·························58
제4장. 결 론 ··················································································63
제1절 연구결과 ······················································································65
제2절 시사점 및 정책제언 ····································································67
참고문헌 ·································································································69
부록. 국가별 새로운 의료기기로 지정받은 제품 현황 ··············73
1. 미국 혁신의료기기(Breakthrough Device) 지정 제품 현황 ········75
2. 중국 혁신의료기기 특별승인절차(?新??器械特???程序)
지정 제품 현황 ·················································································95
출처 : 한국보건산업진흥원
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