국가공인 의료기기 규제과학(RA) 전문가 제5권 : 해외 인허가 제도

제1장 미국 의료기기 제품인증 절차
1. 미국 의료기기 제품인증 절차 ··········································································································· 3
1.1 의료기기 정의와 의료기기법 ····················································································································· 4
1.2 의료기기 인허가 ······································································································································ 22
2. 미국 의료기기 품질관리 ················································································································· 71
2.1 품질관리경영시스템(GMP, Good Manufacturing Practices) ·························································· 71
2.2 시판 후 사후관리(Post-market Surveillance Requirement) ··························································· 82
2.3 법적 요구사항 및 관련규정 ················································································································· 100
제2장 유럽 의료기기 제품인증 절차
1. 유럽 의료기기 제품인증 절차 ······································································································· 109
1.1 의료기기 정의와 의료기기법 ················································································································· 109
1.2 의료기기 인허가 ···································································································································· 160
1.3 의료기기 품질관리 ································································································································· 168
제3장 중국 의료기기 제품인증 절차
1. 중국 의료기기 제품인허가 ············································································································ 235
1.1 의료기기 감독관리 개요 ························································································································ 236
1.2 수입 의료기기 인허가 사전 준비 ········································································································ 258
1.3 신청 및 등록 심사 개요 ······················································································································ 312
1.4 의료기기 판매 후 감독관리 현황 ·········································································································· 321
제4장 일본 의료기기 제품인증 절차
1. 일본 의료기기 인허가 ··················································································································· 333
1.1 일본의 의료기기 관련 규제 법규 ..의약품, 의료기기 등 법.. ····························································· 334
1.2 의료기기 정의와 의료기기법 ················································································································· 342
2. 일본 의료기기 사후관리 ················································································································ 381
2.1 사후관리(시판 후 감시) ························································································································ 381
3. 일본 의료기기 품질관리 ················································································································ 386
3.1 의료기기 품질관리 ································································································································· 386
4. 일본 의료기기 임상시험 ················································································································ 392
4.1 의료기기 임상시험 ································································································································· 392
5. 참고자료 ····································································································································· 397
5.1 일본 의료기기 규제 관련 법령 및 유용한 사이트 ··············································································· 397
제5장 의료기기 단일심사 프로그램(MDSAP)
1. 의료기기 단일심사 프로그램 개요 ································································································ 401
1.1 MDSAP 참여 규제기관 ························································································································· 401
1.2 심사 개발 이유 ······································································································································ 402
1.3 심사 목표 ··············································································································································· 403
2. MDSAP 심사 ································································································································ 403
2.1 심사 절차 ··············································································································································· 403
2.2 심사 주기 ··············································································································································· 405
2.3 심사 종류 ··············································································································································· 406
2.4 심사 준비 ··············································································································································· 408
2.5 심사 수행 ··············································································································································· 409
2.6 심사 수행 탐색 ······································································································································ 409
2.7 심사 기간 ··············································································································································· 411
2.8 심사 통보 ··············································································································································· 412
2.9 MDSAP 심사의 구성 ····························································································································· 413
2.10 MDSAP 부적합 처리 ··························································································································· 447
참고문헌 ············································································································································· 420