국가공인 의료기기 규제과학(RA) 전문가 제2권 : 사후관리

제1장 의료기기 표시.기재의 이해
1. 의료기기 용기 등의 기재사항 및 첨부문서 기재사항 ······································································· 3
2. 의료기기 표시.기재 관련 법령 ········································································································· 4
2.1 용기 등의 기재사항 ··································································································································· 7
2.2 첨부문서 기재사항 ····································································································································· 9
3. 의료기기 표시.기재 사항 ················································································································ 10
3.1 일반적 기재 요령 ···································································································································· 11
3.2 의료기기 표시.기재 방법 ························································································································ 12
3.3 의료기기 표시.기재 권장사항 ················································································································· 22
4. 의료기기 표시.기재 위반사항 처분 등 ··························································································· 23
4.1 의료기기 표시.기재 위반사항 ················································································································· 23
4.2 의료기기 표시.기재 처분사항 ················································································································· 24
제2장 광고
1. 의료기기 광고 개요 ························································································································ 29
2. 의료기기 광고사전심의 제도 ··········································································································· 29
2.1 광고사전심의 제도 도입 배경 ··············································································································· 29
2.2 광고심의 대상 매체 ································································································································· 30
2.3 의료기기 광고사전심의 기준 및 절차 등 ······························································································· 32
2.4 재심의 및 심의 내용의 변경 ··················································································································· 39
2.5 심의 결과 확인 및 표시 방법 ················································································································· 39
3. 금지되는 광고 ································································································································· 41
3.1 금지되는 광고의 범위 ··························································································································· 41
3.2 행정처분기준 ······································································································································ 43
제3장 부작용
1. 의료기기 부작용 등 안전성 정보 관리제도의 배경 ········································································· 47
2. 의료기기 부작용 등 안전성 정보에 관한 규정 ··············································································· 47
2.1 용어 정의 ················································································································································· 47
2.2 안전성정보의 관리체계 ·························································································································· 49
2.3 부작용 정보 수집대상 및 방법 ··············································································································· 50
2.4 의료기기 안전성 정보의 보고 ················································································································· 51
2.5 안전성 정보의 검토 및 평가 ················································································································· 76
2.6 후속조치 등 ············································································································································· 80
제4장 재평가
1. 의료기기 재평가 제도의 배경 ········································································································· 87
1.1 배경 ·························································································································································· 87
1.2 용어의 정의 ············································································································································· 87
2. 재평가 방법 및 절차 ······················································································································ 88
2.1 재평가 대상 ············································································································································· 88
2.2 재평가 실시 대상 등에 대한 공고 ·········································································································· 89
2.3 재평가 제출자료 ······································································································································ 90
2.4 재평가의 신청 ········································································································································ 112
2.5 재평가 검토 결과 열람 및 의견제출 ···································································································· 114
2.6 재평가 결과 확정 ·································································································································· 114
2.7 재평가 결과 공고 ·································································································································· 114
2.8 후속조치 ················································································································································· 114
3. 행정처분 기준 ······························································································································· 115
제5장 재심사
1. 의료기기 재심사 제도의 배경 ······································································································· 119
1.1 배경 ························································································································································ 119
1.2 용어의 정의 ··········································································································································· 119
2. 재심사 방법 및 절차 ···················································································································· 121
2.1 대상 및 기간 ········································································································································· 122
2.2 업무기준서 ············································································································································· 123
2.3 시판 후 조사 계획 보고서 ···················································································································· 124
2.4 시판 후 조사 실시 기준 ························································································································ 130
2.5 시판 후 조사 연차보고서 ······················································································································ 131
2.6 재심사 신청 ··········································································································································· 134
2.7 재심사 실시 및 결과 통지 ···················································································································· 136
2.8 후속조치 ················································································································································· 138
2.9 문서 및 자료 등의 보존 ························································································································ 138
제6장 의료기기 추적관리
1. 추적관리대상 의료기기 ················································································································· 141
1.1 의료기기법령상의 추적관리대상 의료기기 ···························································································· 141
1.2 식약처장이 소재 파악의 필요성이 있다고 정하여 고시하는 의료기기 ··············································· 142
2. 추적관리 기록 및 방법 ················································································································· 144
2.1 추적의 시작 ··········································································································································· 144
2.2 추적관리 기록 ········································································································································ 144
2.3 자료제출 및 의무 ·································································································································· 146
2.4 추적의 종료 및 보존 ····························································································································· 146
2.5 추적관리대상 표준코드 운영 ················································································································· 147
2.6 추적관리대상 의료기기 제출 양식 ········································································································ 148
2.7 행정처분 ··············································································································································· 153
제7장 보고와 검사, 회수.폐기, 사용중지명령
1. 보고와 검사 ·································································································································· 157
2. 회수.폐기 ····································································································································· 158
2.1 회수.폐기 및 공표 명령 등 ·················································································································· 158
2.2 회수 대상 의료기기 ······························································································································· 158
2.3 위해성 정도 평가 ·································································································································· 160
2.4 회수절차 ················································································································································· 162
2.5 이의 신청(정부 회수에 한함) ··············································································································· 174
2.6 행정처분 ··············································································································································· 185
3. 사용중지 명령 ······························································································································· 187
제8장 벌칙, 과징금, 과태료, 행정처분
1. 벌칙 ·············································································································································· 191
1.1 벌칙의 정의 ··········································································································································· 191
1.2 벌칙 관련 법령 내용 ····························································································································· 191
2. 과징금 ··········································································································································· 193
2.1 과징금의 정의 ········································································································································ 193
2.2 과징금 관련 법령내용 ··························································································································· 193
2.3 과징금의 산정 기준 ······························································································································· 194
2.4 과징금 전환 기준 ·································································································································· 196
3. 과태료 ··········································································································································· 197
3.1 과태료의 정의 ········································································································································ 197
3.2 과태료 관련 법령 내용(.의료기기법. 제56조) ···················································································· 197
3.3 과태료 부과기준(.의료기기법. 시행령 제14조) ·················································································· 198
4. 행정처분 ······································································································································· 199
4.1 행정처분의 정의 ···································································································································· 199
4.2 행정처분 관련 법령 내용 ······················································································································ 199
제9장 의료기기 표준코드(UDI)
1. 의료기기 표준코드 제도 ················································································································ 225
1.1 의료기기 표준코드의 정의 ···················································································································· 225
1.2 추진배경 ················································································································································· 225
1.3 추진 현황 및 추진 계획 ························································································································ 227
2. 의료기기 표준코드 제도 관련 법령 ······························································································· 228
3. 국외 의료기기 표준코드 관련 현황 ······························································································· 233
참고문헌 ············································································································································· 236