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- ISO 15378 Primary Packaging Materials
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- ICMC NEWS & LIBRARY
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- 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
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ICMC (International Certification Management Center Co., Ltd.)
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[의료기기 인허가] 수입의료기기 제조소 GMP 심사 세부운영 가이드라인 개정
- Admin Hits:677
- 2022-06-29 13:19:00
안녕하세요, ICMC 해외인증경영센터입니다.
수입의료기기 제조소 GMP 심사 세부운영 가이드라인이 개정(제7개정)됨에 따라 전문 게시합니다.
(첨부파일 참조)
특히 최근 주요 보완사항으로 등급별 적용되는 사용적합성 요구사항* 시행시기를 확인 바랍니다.
)
출처: 수입의료기기+제조소+GMP+심사+세부운영+가이드라인(공무원+지침서)(지침서-0088-04)
제조/수입 GMP 심사 문의는 아래로 연락주시기 바랍니다.
T : 02) 851-3111
E : icmcert@naver.com
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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.
- TEL : +82-2-851-3111
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