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