제1차 의료기기산업 실태조사

목 차

1장 조사 개요

제1절 추진 배경 및 목적

1. 조사배경 및 목적···································································10

추진배경············································································10

법적근거············································································10

2. 조사 대상··············································································11

조사항목 및 범위···································································11

2장 조사 결과

제1절 의료기기 규제 및 정책 동향

1. 국내 의료기기산업 규제 및 주요 정책········································· 15

규제제도············································································ 15

산업 육성정책······································································ 16

2. 해외 의료기기산업 규제 및 주요 정책········································ 17

국가별 혁신의료기기 지정 제도··············································· 19

3. 국가별 혁신의료기기 관리 제도················································ 19

국가별 혁신의료기기 지정 및 허가 현황··································· 20

제2절 의료기기 산업 및 시장 현황

1. 글로벌 의료기기 산업 및 시장 현황··········································· 26

글로벌 의료기기 시장 규모···················································· 26

글로벌 의료기기 수출·입 규모················································ 28

글로벌 의료기기 주요 기업···················································· 30

글로벌 의료기기산업 투자 및 인수합병·····································3 1

2. 국내 의료기기 산업 및 시장 현황··············································35

국내 의료기기 산업 규모························································35

국내 의료기기 기업 현황······················································· 39

국내 의료기기산업 인력 현황················································· 43

3. 국내 의료기기 사용 현황························································ 46

의료기관 종별 국산의료기기 사용 현황····································· 46

제품 분류별 국산의료기기 사용 현황········································ 48

의료기관 종별 주요 보유 제품 및 국산의료기기 사용 현황············· 51

제3절 의료기기 연구개발 및 기술(제품) 현황

1. 국가연구개발 투자 현황··························································54

의료기기 국가연구개발 투자 규모············································54

분야별 의료기기 국가연구개발 투자 규모 ··································57

2. 의료기기 임상시험 현황··························································58

의료기기 임상시험기관 현황···················································58

의료기기 임상시험계획 승인 현황············································59

분야별 의료기기 임상시험계획 승인 현황···································59

3. 국가별 의료기기 기술 경쟁력·················································· 60

의료기기 분야별 기술 수준····················································· 61

의료기기 분야별 기술 성숙도··················································62

4. 의료기기 제품화 현황·····························································65

의료기기 신규 신고·인증·허가 현황··········································65

분야별 의료기기 신규 신고·인증·허가 제품·································67

3장 기업 실태조사

1. 일반 현황·············································································72

기업 유형 및 업종 분류···························································72

2. 인력 현황 ············································································74

직무별 인력 분포··································································74

3. 연구개발 및 제조 현황····························································78

연구개발 수행······································································78

연구개발비········································································· 80

제품 개발 건수 및 기간···························································81

제조 주체 및 원자재 수급······················································· 82

외부협력 수행(연구, 제조, 마케팅 분야 전체)····························· 84

4. 시장진출 현황······································································ 86

의료기기 기업 매출 총액(추정)··············································· 86

국내 주요 유통 판매처···························································87

해외 법인 설립···································································· 88

4장 참고 자료

1. 정책 의료기기산업 8대 중점 분야에 따른 산업 분류체계 ···············92

요약···················································································92

세부 내용 ···········································································92

2. 국가과학기술표준분류와 8대 분야 중점 의료기기산업 분류체계 매칭············································ 94