수행기관 : 서울대학교병원

수행 연구원 : 안원식

기관 : 식품의약품안전처 / 의료기기안전국 의료기기안전정책과

 

 

최종연구목표
○주요 선진국의 의료기기 임상시험 관리제도 비교 연구
-주요선진국(미국, 일본, 영국, 독일, 호주, 이스라엘)의 의료기기 임상시험 관리제도 현황 파악
-선진국의 의료기기 규격관리제도와 의료기기 임상시험 연관성 파악
○국내 임상시험 제도 개선 방안 마련
-국내 임상시험 관리제도 현황 연구
-의료기기 국가표준규격에 대한 현황 파악
-선진국과 국내의료기기 규격관리제도와 임상시험 관리제도 비교 분석하여 개선 방안도출

연구내용 및 방법
○국내외 의료기기 임상시험 관리제도 현황 조사
-의료기기산업 선진국인 미국, 일본, 영국, 독일, 호주, 이스라엘을 대상으로 하기 항목 조사
- 임상시험 관리기관 및 업무, 조직 등에 관한 조사
-임상시험 신청, 임상시험계획서 사전 검토, 보완 및 승인 절차
-임상시험 이상반응 등의 보고 절차
-의료기기 임상시험 종료에 따른 보고 절차
-임상시험 실시기관 실태
-의료기기 관리제도의 국제공조를 위한 모임인 GHTF에서 제시하는 임상시험 관리제도 조사
-각국 임상시험 관리제도 특성 비교 및 장단점 조사 분석
○국내외 의료기기 규격 관리제도 현황 조사
-의료기기 규격관리 국제기구인 GHTF에서 제시하는 의료기기 규격과 관리제도 조사
-CE, FDA, 후생성 규격과 GHTF 규격 비교 연구
-식약청, 지식경제부 의료기기 규격 관리제도 현황 조사
-국가참조표준센터의 의료기기 규격 현황조사
○국내 의료기기 임상시험 관리제도 개선 방안(안) 제시
-의료기기 국제규격에 적합한 국내 의료기기 규격관리제도 초안 제시
-규격관리제도와 연계된 의료기기 임상시험 승인 절차 및 사후관리 방안(안) 제시

기대성과 및 활용방안
○의료기기 임상시험 관리제도의 국제적인 객관성 확보
-의료기기 임상시험의 국제적인 상호인증을 위한 기반 마련
-FDA와 후생성의 실사에 대비한 임상시험 관리제도 정비
○임상시험 관리제도의 개선방안 마련을 위한 자료로 활용
-향후 임상시험 관리제도 개선방안 마련을 위한 기초 자료로 활용
○국제 의료기기 규격관리 협의체 가입을 위한 자료로 활용
-의료기기 규격관리 국제기구인 GHTF에 가입하기 위한 제반 기초 자료 마련에 활용"

 

 

 

Ⅰ. 총괄연구개발과제 요약문 ···································································································· 7

Ⅱ. 총괄연구개발과제 연구결과 ······························································································11

제1장 총괄연구개발과제의 목적 및 필요성 ·······················································································11

1.1 총괄연구개발과제의 목표 ··································································································································11

1. 연구의 필요성 ························································································································································11

2. 최종 연구 목표 ······················································································································································12

1.2 총괄연구개발과제의 목표달성도 ·····················································································································13

제2장 총괄연구개발과제의 내용 및 방법 ···························································································14

1. 주요 선진국의 의료기기 임상시험 관리제도 분석 ······················································································14

2. 국내 임상시험 제도 개선 방안 마련 ················································································································14

2.2 연구 방법 ·······························································································································································15

1. 주요 선진국의 의료기기 임상시험 관리제도 분석 ························································································15

2. 국내외 의료기기 규격 관리제도 현황 조사 ····································································································16

3. 국내 의료기기 임상시험 관리제도 개선 방안 제시 ······················································································17

제3장 총괄연구개발과제의 최종결과 및 고찰 ···················································································18

3.1 국ㆍ내외 의료기기 임상시험 관리제도 현황 조사 ····················································································18

1. 국내 의료기기 임상시험 관리제도 ····················································································································18

2. 미국 의료기기 임상시험 관리제도 ····················································································································33

3. 일본 의료기기 임상시험 관리제도 ····················································································································50

4. 영국 의료기기 임상시험 관리제도 ····················································································································66

5. 독일 의료기기 임상시험 관리제도 ··················································································································84

6. 호주 의료기기 임상시험 관리제도 ····················································································································91

3.2 국내ㆍ외 의료기기 규격 관리제도 현황 조사 ··························································································108

3.3 국내ㆍ외 의료기기 임상시험 관리제도 특성 비교 ··················································································112

3.4 국내 의료기기 임상시험 관리제도 개선 방안 제시 ················································································116

1. 임상시험계획서 사전 검토 ································································································································116