국가공인 의료기기 규제과학(RA) 전문가 1~5 세트 한국의료기기안전정보원 공식교육교재  [ 전5권 ]  
한국의료기기안전정보원 저  | 좋은책 차오름

※목차
[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...