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- 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
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- ISO 37001 Anti-bribery Management
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ICMC (International Certification Management Center Co., Ltd.)
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Medical Devices FDA
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Medical Devices FDA
[FDA] FY2020 Medical divice User fee Amendments (MDUFA) 공지
- Admin Hits:549
- 2019-10-11 19:51:00
미국 식약처 홈페이지에서 FY 2020 User fee 가 지난 9월 공지되었습니다.
각 허가 항목별 User fee가 확인가능하며,
Standard busines/Small business 별 상이한 점 참조 부탁드립니다.
하기 링크에서 확인 가능하오니, 업무에 많은 참조 바랍니다.
https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa
감사합니다.
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