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ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
- NOTICE
- CUSTOMER
- ABOUT ICMC
- DOMESTIC RA
- GLOBAL RA
-
ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
- ISO 45001 Occupational Health and Safety
- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
- ISO 9001 Quality Management
- ISO 14001 Environmental Management
- ISO 10002 Customer Satisfaction
- ISO 22301 Business Continuity
- ISO 37001 Anti-bribery Management
- TRAINING CENTER
- ACHIEVEMENT
- ICMC NEWS & LIBRARY
- NOTICE
ICMC NEWS & LIBRARY
ICMC (International Certification Management Center Co., Ltd.)
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ICMC NEWS & LIBRARY
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Medical Devices MFDS
icmcert@naver.com
+82-2-851-3111
Medical Devices MFDS
[MFDS] 의료제품 허가·심사 공식 소통채널 운영 가이드라인(민원인 안내서) 제정 안내
- Admin Hits:686
- 2020-08-28 13:55:00
안녕하세요,
식약처(융복합혁신제품지원단 융복합기술정책팀)에서는 허가·심사 행정의 예측가능성 및 투명성 제고를 통한
혁신 의료제품의 신속한 시장진입을 지원하기 위하여 신청인과 식약처 담당자 간 신설·운영되는 ‘공식 소통채널’을 안내하고자,
의료제품 허가·심사 공식 소통채널 운영 가이드라인(민원인 안내서)을 제정하였습니다.
업무에 참고하여 주시기 바랍니다.
○ 주요내용
- 의료제품 허가·심사 ‘공식 소통채널’ 운영 체계 및 절차
- 기타 ‘기존 소통채널’ 운영
- 소통채널 활용 예시 등
감사합니다.
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- Company : ICMC (International Certification Management Center Co., Ltd.)
- CEO : Bong Ju Kim
- Address: 16 Digital-ro 32-ga-gil, Guro-gu, Seoul (Guro-dong) Partner Tower 2nd Room 1001.
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