html 소스복사 <p>제1장. 서론 ·························································································1<br> 제1절 연구의 배경 및 목적 ····································································3<br> 제2절 연구 내용 및 방법 ········································································4<br> 제2장. 주요국의 의료기기 정의 및 분류체계 ·································7<br> 제1절 미국 의료기기 정의 및 분류체계 ·················································9<br> 제2절 유럽 의료기기 정의 및 분류체계 ···············································15<br> 제3절 중국 의료기기 정의 및 분류체계 ···············································21<br> 제4절 한국 의료기기 정의 및 분류체계 ···············································26<br> 제5절 국가별 의료기기 분류체계 특징 분석 ·······································30<br> 제3장. 국가별 새로운 의료기기 관리 현황 ··································37<br> 제1절 미국 새로운 의료기기 관리 현황 ···············································39<br> 제2절 중국 새로운 의료기기 관리 현황 ···············································47<br> 제3절 한국 새로운 의료기기 관리 현황 ···············································54<br> 제4절 국가별 새로운 의료기기 관리 현황 특징 분석 ·························58<br> 제4장. 결 론 ··················································································63<br> 제1절 연구결과 ······················································································65<br> 제2절 시사점 및 정책제언 ····································································67<br>참고문헌 ·································································································69</p> <p>부록. 국가별 새로운 의료기기로 지정받은 제품 현황 ··············73<br> 1. 미국 혁신의료기기(Breakthrough Device) 지정 제품 현황 ········75<br>2. 중국 혁신의료기기 특별승인절차(创新医疗器械特别审查程序)</p> <p>지정 제품 현황 ·················································································95<br> </p>
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