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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
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ICMC (International Certification Management Center Co., Ltd.)
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Medical Devices FDA
icmcert@naver.com
+82-2-851-3111
Medical Devices FDA
[FDA] User fee 신청 양식 개정
- Admin Hits:592
- 2019-07-26 19:49:00
FDA User Fee는 아래와 같이 구분됩니다.
1) For a U.S Business - 미국지사가 있는 경우
2) For a Foreign Business - 미국지사가 없이, 한국 본사만 있는 경우
한국 제조업체들은 보통 Foreign Busines 에 속하며,
Form 3602A에 따라 진행하면 됩니다.
해당 양식이 개정됨에 따라 첨부와 같이 공유합니다.
감사합니다.
*출처 : https://www.fda.gov/about-fda/reports-manuals-forms/forms
1) For a U.S Business - 미국지사가 있는 경우
2) For a Foreign Business - 미국지사가 없이, 한국 본사만 있는 경우
한국 제조업체들은 보통 Foreign Busines 에 속하며,
Form 3602A에 따라 진행하면 됩니다.
해당 양식이 개정됨에 따라 첨부와 같이 공유합니다.
감사합니다.
*출처 : https://www.fda.gov/about-fda/reports-manuals-forms/forms
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- Company : ICMC (International Certification Management Center Co., Ltd.)
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- Address: 16 Digital-ro 32-ga-gil, Guro-gu, Seoul (Guro-dong) Partner Tower 2nd Room 1001.
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