분야
기계,보건의료
발행기관
한국보건산업진흥원
발행일
2021.03
URL
개요
‘의료기기’란 사람 또는 동물에게 단독 또는 조합하여 사용되는 기구?기계?장치?재료 또는 이와 유사한 제품으로서 질병의 진단?치료 또는 예방의 목적으로 사용되거나, 구조 또는 기능의 검사?대체 또는 변형의 목적으로 사용되는 제품 등을 말한다. 의료기기산업은 다양한 제품군으로 점차 복잡화 및 다양화되며, 정부의 의료정책 및 관리제도의 영향도가 높고, 의료기관 등 수요가 한정되어 있으며, 연구개발에 대한 지속적 투자가 필요하다. 의료기기 분류는 크게 일반분류와 산업?시장 분류로 구분할 수 있다. 일반분류는 식약처 품목분류, 국가과학기술표준분류, 지식경제부 의료기기 분류 등으로 구성되며 주로 품목 및 기술단위 분류이며, 산업?시장분류는 시장 및 산업관점으로 분류한 체계이다.
요약문 / 1
제1장 연구 개요 / 7
1. 의료기기산업의 정의 및 특성 ································································· 7
2. 의료기기 분류체계 ················································································· 10
제2장 의료기기산업 동향 / 19
1. 국내 의료기기산업 특성 및 정책 동향 ················································· 19
2. 의료기기산업 육성 및 혁신의료기기 지원법 ········································ 20
3. 체외진단 의료기기법 ·············································································· 24
4. 코로나19로 인한 의료기기산업 영향 ···················································· 26
제3장 세계 의료기기산업 동향 / 31
1. 세계 의료기기 시장 동향 ······································································ 31
2. 의료기기 시장 동향 ··············································································· 34
제4장 국내 의료기기산업 동향 / 43
1. 시장 동향 ································································································ 43
2. 주요 교역국에 대한 수출입 동향 ·························································· 63
제5장 국내 의료기기산업 연구개발 동향 / 70
1. 개요 ········································································································· 70
2. 의료기기산업 기업체 연구개발 현황 ····················································· 71
제6장 결언 / 81
1. 산업동향 ································································································· 81
2. 산업전망 및 함의 ··················································································· 83
참고문헌?? /?? 89
부록?? /?? 91
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