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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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In Vitro Diagnostic KGMP
icmcert@naver.com
+82-2-851-3111
In Vitro Diagnostic KGMP
[MFDS] 수입 체외진단의료기기 제조소 GMP 심사 세부운영 지침(공무원지침서) 제정 안내
- Admin Hits:960
- 2020-07-27 13:54:00
안녕하세요.
식약처(의료기기관리과)에서는 수입 체외진단의료기기 GMP 심사 업무의 일관성 및 투명성 제고를 위해
「체외진단의료기기 제조 및 품질관리 기준」 제정 사항 등을 반영하여
수입 체외진단의료기기 제조소 GMP 심사 세부운영 지침(공무원지침서)를 제정하였습니다.
해당 민원인안내서는 한국의료기기산업협회 홈페이지 하기 경로를 통해 열람하실 수 있습니다.
*한국의료기기산업협회 홈페이지 http://www.kmdia.or.kr/KO/ → 자료공유
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