총 101페이지

Ⅰ. 동물용의료기기 관련 규정············································ 1
Ⅱ. 동물용의료기기 제조(수입)업 허가신청····················· 3
1. 동물용의료기기 제조업 허가신청·····································3
1) 동물용의료기기 제조업 허가신청서 작성요령·················3
2) 동물용의료기기 제조업소의 시설 및 품질관리체계········5
2. 동물용의료기기 수입업 허가신청·····································7
1) 동물용의료기기 수입업 허가신청서 작성요령·················7
2) 동물용의료기기 수입업소의 시설 및 품질관리체계········9
3. 동물용의료기기 제조(수입) 품목신청서 작성요령········10
Ⅲ. 동물용체외진단시약의 기술문서 심사 지침서········· 16
Ⅳ. 동물용체외진단시약의 기술문서 작성요령·············· 23
1. 제품명, 형상 및 구조·····················································23
1) 제품명(상품명, 품목명, 모델명)······································23
2) 형상 및 구조····································································24
2. 원재료 또는 성분 및 분량·············································27
3. 제조방법···········································································29
4. 성능··················································································30

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