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의료기기 제조(수입) 허가·신고·심사 등 민원처리 안내서
ADMIN  2013-09-09 14:08:47, 조회 : 1,986, 추천 : 581
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식약청 의료기기안전국에서는 잠재적 위해성이 낮은
1, 2 등급 의료기기에 대한 산업계의 자율성을 확대하고
제조 현장에 대한 품질관리 체계를 강화하는 등 의료기기
허가 관리 제도를 대폭 개선한 바 있습니다.
주요 개선 내용으로 종전 2등급 의료기기의 경우 본청에서 허가 심사를
하였으나, 식약청장이 지정한 심사기관에서 기술문서 심사를 받은 후, 관할
지방청장이 허가하도록 하고 있습니다. 이는 선택과 집중을 통한 효율적인
허가·심사 체계 개편을 위한 것이며, 본 제도가 빠르게 정착되고 관련 기관
및 업체의 업무 수행이 원활히 이루어 질수 있도록 본 안내서를 발간
하게 되었습니다.
본 안내서의 주요 내용으로는 ‘제조(수입) 업 및 허가(신고) 절차, GMP
심사 절차, 사후관리 절차, 전자민원시스템 신고방법 등에 대한 안내’를
하고 있으며, 의료기기 업무에 대한 투명성과 공정성을 향상시킬 수 있으
리라 기대하고 있습니다. 동 안내서가 관련 업무 수행에 널리 활용되어 많
은 도움이 되시기를 기대합니다.
아울러 앞으로도 지속적인 안내서를 마련할 예정이며, 의료기기 제도가 의료
기기 산업 발전에 조금이나마 기여가 되었으면 합니다.
감사합니다.

2012년 4월

의료기기안전국장

목 차
Ⅰ. 의료기기 제조(수입)업 허가 절차 ······································1
Ⅱ. 의료기기 허가 절차 ································································2
Ⅲ. 의료기기 신고 절차 ································································8
Ⅳ. 의료기기 GMP 심사 절차 ····················································9
Ⅴ. 의료기기 사후관리 절차 ······················································10
Ⅵ. 구비서류 및 심사기준 ··························································14
1. 제조업(수입업) 허가·····································································14
2. 제조업(수입업) 변경허가·····························································16
3. 제조(수입) 허가·············································································21
4. 제조(수입) 변경허가·····································································25
5. 제조(수입) 신고·············································································32
6. 제조(수입) 변경신고·····································································34
7. 의료기기 기술문서 등 심사························································36
8. 의료기기 임상시험계획 승인······················································40
9. 의료기기 임상시험계획 변경승인··············································43
10. 제조(수입)업의 휴업/폐업/재개의 신고·································45
11. 의료기기 허가증 등 재교부 신청············································46
12. 의료기기 허가증 등 갱신 신청················································47
13. 의료기기 해당여부 질의····························································48
14. 영문증명서····················································································49
15. 시험용 의료기기 확인································································51
16. 의료기기 GMP 심사···································································53
17. 의료기기 재심사··········································································55
18. 의료기기 재평가··········································································57
19. 의료기기 광고사전심의 신청····················································58
20. 의료기기 부작용 보고································································60
21. 의료기기 자발적 회수계획 보고··············································61
22. 전시목적 의료기기 신청····························································66
<별첨1> 품목류 허가 대상 의료기기 목록··································68
<별첨2> 기술문서심사기관 심사대상 품목지정공고문··············69
<별첨3> 의료기기 전자민원시스템 신고 방법····························70
<별첨4> 「의료기기제조및품질관리기준」[별표1]과[별표3] ··············· 77

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