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

2024년 관계부처 합동 '바이오헬스 인재양성 사업안내서'를 발간하여 온라인으로 열람하실 수 있도록 안내드립니다.

보건복지부 등 9개 부처의 바이오헬스 분야 인재양성 사업에 대한 세부 정보를 참고하여 주시고,

각 사업별 추가 정보는 안내된 문의처 및 사이트를 통해 확인하시면 됩니다.

'2024 바이오헬스 인재양성 사업안내서' 책자 수령이 필요한 경우,

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 * 사업안내서 수령 등 문의 : 한국보건산업진흥원 인재양성정책팀, mediscientist@khidi.or.kr / 043-713-8443

바이오헬스 분야 인재양성 사업 및 사업안내서에 대한 많은 관심과 참여에 감사드립니다.

<2024년 관계부처합동 바이오헬스 인재양성 사업안내서>

CONTENTS

- 2024 바이오헬스 인재양성 사업안내서 소

- 바이오헬스 인재양성 사업안내서 가이드맵

- 개인지원사업 - 바이오헬스 전반 / 제약 / 의료기기 / 디지털헬스케어 / 화장품

- 기관지원사업 - 바이오헬스 전반 / 제약 / 의료기기 / 디지털헬스케어

차례

PART 1 의료 해외진출 지원배경

PART 2 의료 해외진출 지원사업 안내

PART 3 의료 해외진출 신고

PART 4 의료 해외진출 우수사례

<차례>

 Ⅰ. 사업 배경 및 필요성

 Ⅱ. 국내 보건산업 수출 현황과 정책

 Ⅲ. GVC 관련 대내외 환경 분석

 Ⅳ. GVC 전략품목 선정 및 분석

 Ⅴ. 보건산업 GVC 민감도 요인 분석

 Ⅵ. 보건산업 GVC 전·후방참여도 분석

 Ⅶ. 마치며

 참고 문헌

CONTENTS

PART 1. 보건산업 통계

 • 글로벌 보건산업 수출입 동향

PART 2. 보건의료 통상 지역별/쟁점별 분석

 • 제1장 제약/바이오 산업과 경제안보

 • 제2장 WTO 서비스국내규제(SDR) 규범 채택의 의의와 보건서비스산업에의 영향

 • 제3장 EU의 통상정책을 통해 본 의약품의 공급망 강화 방안

 • 제4장 보건산업과 기업의 사회적 책임: 독일 공급망실사법 시행 및 시사점을 중심으로

 • 제5장 중국 의련체 정책을 활용한 한국 보건산업 진출 전략

 • 참고 문헌

1. 미국

2. 캐나다

3. 멕시코

4. 브라질

5. 아르헨티나

6. 에콰도르

7. 우루과이

8. 칠레  

9. 페루

1. 네덜란드

2. 노르웨이

3. 덴마크

4. 독일

5. 루마니아

6. 스웨덴

7. 스페인

8. 영국

9. 오스트리아

10. 체코

11. 튀르키예

12. 폴란드

13. 프랑스

14. 헝가리

CONTENTS

01 조사 개요

 1. 조사 배경 및 목적

 2. 조사 개요

 3. 조사 내용

 4. 모집단 정의

 5. 표본 설계

 6. 무응답 대체

 7. 가중치 산출

02 조사 결과 요약

03 바이오헬스산업 조사 결과

 1. 일반 현황

 2. 매출 현황

 3. 인력 현황

 4. 연구개발 현황

 5. 해외 진출 현황

04 제약(의약품)산업 조사 결과

05 의료기기산업 조사 결과

06 화장품산업 조사 결과

07 건강기능식품산업 조사 결과

2. 의료기관의 ESG

3. ESG 인식도 및 경영현황 조사

4. 국내 의료기관 ESG 사례

5. 해외 의료기관 ESG 사례

6. 시사점

7. 참고 문헌

목차 

1. 동남아 개요

2. 인도네시아

3. 베트남

4. 태국