대한민국 대표 미래 먹거리, 헬스케어가 답이다!
새로운 성장동력으로 떠오르는 의료기기산업의 ‘개발’부터 ‘실용화’까지
글로벌 헬스케어 트렌드와 다양한 사례별 ABC 노하우

이 책은 이 분야 국내 권위자인 유규하 교수를 통해 의료기기 산업 분야의 핵심 노하우를 소개한다. 종래의 의료기기 기술개발(R&D) 교육과 더불어 핵심 과목인 ‘의료기기 글로벌 허가인증제도’를 통해 산업현장에서 의료기기의 제품기획, 연구, 개발, 생산, 허가, 유통 등의 업무수행이 가능하도록 실질적이고 종합적인 지식을 제공하고 있다. 또한 저자의 다년간의 식품의약품안전처 의료기기 허가심사 분야의 공직 경험과 대학에서의 교육경험을 토대로, 각국의 의료기기법을 비롯해 국가별 규제적 측면에서의 문제점과 대응방안, 사용실태 등에 대한 글로벌 수준의 전문지식을 쌓아 해외진출을 겨냥한 융합적 실무형 전문가를 양성할 수 있도록 했다. 이 책은 의료기기 산업에 관심이 있는 학부생, 대학원생부터 의료기기 규제 관련 업무를 수행하는 실무자에 이르기까지 폭넓은 독자층이 이해하기 쉽게 기술되었으며, 최신 글로벌 헬스케어 트렌드까지 담고 있다.

제1장__대한민국 의료기기 허가인증제도
1. 의료기기 법체계 12
1.1 의료기기 법령의 이해 ··································································12
1.2 의료기기 관련 행정기관 ·······························································17
2. 의료기기 인허가 21
2.1 의료기기 제조(수입)업 허가 ··························································21
2.2 의료기기 제조(수입) 신고 및 허가 ·················································22
2.3 기술문서 심사 ·············································································28
3. 의료기기 임상시험 36
3.1 개요 ··························································································36
3.2 의료기기 임상시험 관련 규정 ·······················································37
3.3 임상시험계획서에 포함되어야 할 사항 ···········································37
3.4 임상시험 관련자별 책임과 역할의 이해 ·········································39
3.5 의료기기 임상시험의 이해 ···························································40
4. 의료기기 품질관리 43
4.1 개요 ··························································································43
4.2 의료기기 품질관리 관련 규정 ·······················································44
4.3 의료기기 제조 및 품질관리기준 적합성 평가?심사 ···························46
4.4 GMP 심사 신청 시 제출자료 ························································48
4.5 의료기기 제조 및 품질관리 적합성 평가기준 ···································51
4.6 의료기기 제조 및 품질관리기준 적합성 평가 구분 ···························55

제2장__미국 의료기기 허가인증제도
1. 의료기기 법체계 59
1.1 규제당국 ·····················································································59
1.2 의료기기 정의 ·············································································61
1.3 등급분류 ·····················································································63
2. 의료기기 인허가 64
2.1 미국 인허가 절차 ·········································································64
2.2 시판전 승인 절차 ·········································································65
3. 의료기기 임상시험 72
3.1 임상시험 관리기관 ········································································72
3.2 의료기기 임상시험계획 승인(Investigational Device Exemption,
IDE) ·································································································74
3.3 임상시험관리기준(Good Clinical Practice, GCP) ·····························80
3.4 임상시험심사위원회(Institutional Review Board, IRB) ·····················82
4. 의료기기 품질관리 85
4.1 품질시스템 규정(Quality System Regulation, QSR) ························85
4.2 사후관리 ······················································································88

제3장__유럽 의료기기 허가인증제도
1. 의료기기 법체계 95
1.1 규제기관 ·····················································································95
1.2 규제 체계 및 관련 법령 ································································99
1.3 의료기기 정의 및 분류 ································································101
2. 의료기기 인허가 110
2.1 시판전 허가 절차 ········································································110
3. 의료기기 품질관리 114
3.1 품질경영시스템 ···········································································114
3.2 사후관리 ····················································································117

제4장__중국 의료기기 허가인증제도
1. 의료기기 법체계 123
1.1 의료기기 법령의 이해 ·································································123
1.2 의료기기 규제기관 ······································································124
2. 의료기기 인허가 126
2.1 시판전 신고 및 등록 절차 ···························································126
3. 의료기기 임상시험 133
3.1 중국의 의료기기 임상시험 ···························································133

제5장__일본 의료기기 허가인증제도
1. 의료기기 법체계 139
1.1 의료기기 규정의 이해 ·································································139
1.2 의료기기 규제기관 ······································································140
1.3 ?약품 및 의료기기법(PMDL)?의 주요 개정 항목 ·····························142
2. 의료기기 인허가 144
2.1 시판전 허가 절차 ·······································································144
3. 의료기기 임상시험 147
3.1 일본의 의료기기 임상시험 ···························································147

제6장__기타 국가 의료기기 허가인증제도
1. 캐나다 152
1.1 분야별 규제 현황 ·······································································152
1.2 규제 감독기관 ···········································································157
1.3 최근 규제 동향 ·········································································158
2. 호주 159
2.1 분야별 규제 현황 ······································································159
2.2 규제 감독기관 ···········································································162
2.3 최근 규제 동향 ··········································································163
3. 브라질 164
3.1 의료기기 규제 감독기관 ······························································164
3.2 의료기기 규제 현황 ····································································165
3.3 브라질 내 최근 규제동향 ····························································169
4. 러시아 170
4.1 규제감독기관 ·············································································170
4.2 분야별 규제현황 ········································································171
4.3 러시아 내 최근 규제동향 ····························································175
5. 영국 175
5.1 규제 감독기관 ···········································································175
5.2 의료기기 규제 현황 ···································································177
6. 인도 179
6.1 규제 기관 ·················································································179
6.2 의료기기 규제 현황 ···································································180
6.3 최근 규제동향 ···········································································185
7. 독일 186
7.1 분야별 규제현황 ········································································186
7.2 규제 감독기관 ···········································································188
8. 프랑스 189
8.1 규제 기관 ·················································································189
8.2 규제 현황 ·················································································191

제7장__의료기기 국제 표준화
1. 국제의료기기규제당국자포럼 (IMDRF) 196
1.1 설립 배경 ·················································································196
1.2 주요 업무 ·················································································199
1.3 협력 기관 ·················································································199
1.4 국내 대응 ·················································································201
2. 의료기기 국제표준화기술문서(STED) 202
2.1 개요 ·························································································202
2.2 STED의 구성 ············································································205
3. 의료기기 품질경영시스템(ISO 13485) 208
3.1 개요 ·························································································208
3.2 의료기기 ? 품질경영시스템 ? 규정에 대한 시스템 요구사항 ···········210
4. 의료기기 위험관리(ISO 14971) 214
4.1 위험관리 국제규격 ······································································215

제8장__최신 의료기기 이슈
1. 디지털 헬스케어 224
1.1 개요 ··························································································224
1.2 모바일 헬스케어 ·········································································227
1.3 빅데이터를 활용한 헬스케어 ·························································230
1.4 글로벌 디지털 헬스케어 규제 동향 ················································234
1.5 국제 헬스케어 표준화 동향 ···························································238
2. 환자맞춤형 정밀의학 240
2.1 환자맞춤형 정밀의학의 배경 및 필요성 ········································240
2.2 환자맞춤형 정밀의학의 산업 동향 ················································242
3. 3D 프린팅 246
3.1 개요 ·························································································246
3.2 3D 프린팅의 정의 ······································································247
3.3 보건산업영역에서의 적용 ····························································248
3.4 의료영역에서의 3D 프린팅 인허가 제도 ········································250