총 101페이지

Ⅵ. 동물용체외진단시약의 기술문서 변경에 관한 사항· 63
1. 변경허가(신고) 관련 규정 및 처리 흐름도···················63
2. 변경사항에 대한 기술문서 심사 여부···························64
1) 기술문서 심사가 불필요한 경우·····································64
2) 기술문서 심사가 필요한 경우·········································64
3) 신규허가 사항···································································65
3. 변경허가 신청시 제출할 자료········································65
Ⅶ. 동물용체외진단시약의 관리일원화에 따른 교체
발급 절차······································································68
1. 배경··················································································68
2. 기술문서 항목내용 변경 사항(의약품→의료기기)······68
3. 기술문서 항목의 변경내용 및 조치사항·······················69
4. 구비서류 및 교체발급 절차···········································70
부록1. 체외진단분석기용 시약 관련 용어 정의·················72
부록2. 동물용 체외진단시약의 범위 및 등급 분류···········84

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