국가공인 의료기기 규제과학(RA) 전문가 제1권 : 시판 전 인허가

제1장 의료기기 산업의 이해
의료기기 산업의 이해와 발전적 동향 중심으로
1. 의료기기 산업의 정의 ······················································································································· 3
1.1 의료기기 산업의 이해와 정의 ··················································································································· 3
1.2 의료기기의 정의(국내 의료기기법) ·········································································································· 4
2. 의료기기 산업의 현황과 미래 ··········································································································· 5
2.1 의료기기 산업의 현황 및 전망 ················································································································· 5
2.2 의료기기 산업의 미래 ····························································································································· 13
3. 의료기기 산업과 시장의 특성 ········································································································· 14
3.1 의료기기 산업의 특성 ····························································································································· 14
3.2 의료기기 시장의 특성 ····························································································································· 19
제2장 의료기기 법령 및 행정체제의 이해
1. 법령 및 고시 제.개정 절차 ············································································································ 23
1.1 개요 ·························································································································································· 23
1.2 의원입법 ··················································································································································· 30
1.3 정부입법(행정입법) ································································································································· 32
1.4 행정규칙 입안절차 ··································································································································· 35
2. 의료기기법령 개요 ·························································································································· 41
2.1 의료기기법의 목적 ··································································································································· 41
2.2 의료기기법 제정 이전의 의료기기 관리 ································································································· 41
2.3 의료기기법의 제정 ··································································································································· 42
2.4 의료기기법의 개정과 변천 ······················································································································ 45
3. 의료기기법령의 구조와 체계 ··········································································································· 51
3.1 의료기기법령의 특징과 구조 ··················································································································· 51
3.3 의료기기법의 구성 ··································································································································· 53
3.4 의료기기법 시행령 및 시행규칙 ············································································································· 54
3.5 의료기기 관련 고시 ································································································································· 55
4. 의료기기 행정 체제 ························································································································ 64
4.1 식품의약품안전처 소관사항 ····················································································································· 64
4.2 의료기기위원회 ········································································································································ 73
4.3 한국의료기기안전정보원 ·························································································································· 75
4.4 관련 기관 ················································································································································· 75
4.5 기타 기관 ················································································································································· 80
제3장 의료기기 용어의 이해
1. 의료기기 기본 용어 ························································································································ 87
2. 의료기기 인허가 관련 용어 ············································································································ 94
제4장 의료기기 인허가제도의 이해
1. 의료기기 인허가 제도 ····················································································································· 99
1.1 의료기기 업허가 ···································································································································· 99
1.2 의료기기 허가.인증.신고 관리 ············································································································· 103
1.3 의료기기 등급분류 기준 ························································································································ 106
2. 의료기기 인허가제도의 관리규정 및 절차 ····················································································· 108
2.1 의료기기 제조(수입)업허가 절차 ·········································································································· 108
2.2 의료기기 신고 절차 ······························································································································· 110
2.3 의료기기 허가.인증 절차 ······················································································································ 112
3. 의료기기 인허가제도와 심사 ········································································································· 124
3.1 심사의 종류 ··········································································································································· 124
제5장 의료기기 기술문서 및 국제표준화 기술문서(STED)의 이해
1. 기술문서의 구성과 요소(임상시험 포함) ······················································································ 147
1.1 기술문서의 구성 ···································································································································· 147
1.2 의료기기 허가.인증 신청서 구성요소 ··································································································· 148
1.3 첨부자료 구성요소 ································································································································· 162
2. 체외진단용 의료기기의 기술문서 구성요소 ··················································································· 185
2.2 체외진단용 의료기기의 첨부자료 요건 및 근거자료 ············································································ 188
2.3 체외진단용 의료기기의 심사자료 면제 등 ···························································································· 196
3. 의료기기 국제표준화기술문서(STED)의 구성 ··············································································· 199
3.1 국제표준화기술문서 ······························································································································· 199
3.2 국제표준화기술문서(STED) 개요 ·········································································································· 203
3.3 첨부자료 ··············································································································································· 258
제6장 의료기기 기준규격 및 시험검사의 이해
1. 의료기기 관련 공통 기준규격 ······································································································· 265
1.1. 개요 및 배경 ······································································································································· 265
1.2 구성 ························································································································································ 266
2. 전기.기계적 안전에 관한 공통 기준규격 ······················································································ 268
2.1 개요 ························································································································································ 268
2.2 구성 ························································································································································ 270
2.3 적용 범위 및 목적 ································································································································ 274
2.4 용어의 정의 ··········································································································································· 274
2.5 요구사항 및 시험의 종류 ······················································································································ 276
2.6 일반 요구사항 ········································································································································ 277
2.7 ME 기기 시험을 위한 일반 요구사항 ·································································································· 283
2.8 ME 기기 및 ME 시스템의 분류 ··········································································································· 286
2.9 ME 기기의 표식, 표시 및 문서 ··········································································································· 287
2.10 ME 기기에서의 전기적 위해요인에 대한 보호 ··················································································· 301
2.11 ME 기기 및 ME 시스템의 기계적 위해요인에 대한 보호 ································································· 317
2.12 원치 않는 과도한 방사선 위해요인에 대한 보호 ··············································································· 331
2.13 과온 및 기타 위해요인에 대한 보호 ·································································································· 333
2.14 제어기와 계측기의 정확도 및 위해한 출력에 대한 보호 ··································································· 341
2.15 ME 기기를 위한 위해상황 및 고장 상태 ··························································································· 343
2.16 프로그램 가능 의료용 전기 시스템 ···································································································· 349
2.17 ME 기기의 구조 ·································································································································· 354
2.18 ME 시스템 ··········································································································································· 363
2.19 ME 기기 및 ME 시스템의 전자파 적합성 ························································································· 370
3. 전자파 안전에 관한 공통 기준규격 ······························································································· 371
3.1 개요 ······················································································································································ 371
3.2 구성 ························································································································································ 372
3.3 적용 범위 및 목적 ································································································································ 375
3.4 요구사항 및 시험의 종류 ······················································································································ 376
4. 생물학적 안전에 관한 공통 기준규격 ··························································································· 392
4.1 개요 ······················································································································································ 392
4.2 구성 ························································································································································ 392
4.3 평가와 시험 ··········································································································································· 397
4.4 요구사항 및 시험의 종류 ······················································································································ 405
5. 체외진단용 의료기기의 기술문서 및 시험검사 ·············································································· 444
5.1 체외진단용 의료기기의 관리 이력 및 제도 개선 변화 ········································································ 445
5.2 체외진단용 의료기기의 등급 체계 ········································································································ 447
5.3 체외진단용 의료기기 품목 체계 ··········································································································· 448
5.4 체외진단용 의료기기 허가·심사 절차 ································································································· 461
5.5 체외진단용 의료기기 기술문서 심사를 위한 자료 ············································································· 464
5.6 체외진단용 의료기기의 첨부자료 요건 및 근거자료 ············································································ 469
5.7 체외진단용 의료기기의 심사자료 면제 등 ···························································································· 477
5.8 체외진단용 의료기기 성능평가 ············································································································· 480
5.9 용어 ························································································································································ 493
제7장 부록
[부록 1] 전기.기계적 안전성 시험 요약 작성 예 ······················································································ 501
[부록 2] 생물학적 안전성 시험 요약 작성 예 ··························································································· 502
[부록 3] 방사선 안전성 시험 요약 작성 예 ······························································································· 503
[부록 4] 전자파 안전성 시험 요약 작성 예 ······························································································· 504
[부록 5] 성능에 관한 시험 요약 작성 예 ·································································································· 505
[부록 6] 물리.화학적 특성 시험 요약 작성 예 ························································································· 506
[부록 7] 동물유래 물질에 대한 안전성 자료 요약 작성 예 ······································································ 507
[부록 8] 안정성 시험 요약 작성 예 ··········································································································· 508
[부록 9] 동물시험 요약 작성 예 ················································································································· 509
[부록 10] 임상시험 요약 작성 예 ··············································································································· 510
참고문헌 ············································································································································· 511