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- ISO13485 In Vitro Diagnostic/ Medical Devices
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- 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
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[FDA] FDA/MDD FY2015 FDA Medical Device User Fee
- Admin Hits:935
- 2014-09-03 19:10:00
FDA/MDD FY 2015 FDA Medical Device User FEE
2014.08.01일 US FDA는 FY 2015 FDA Medical Device User FEE를 아래와 같이 공지하였습니다.
FY15 user fee는 2014년 10월 1일 이후부터 적용되기 때문에 FY14년의 user fee로 납부를 원하는 경우, 2014년 10월 1일 이전에 지불되어야 합니다.
또한, FDA User fee가 납부되지 않은 상태에서 application문서가 제출되는 경우 FDA는 문서에 대한 검토를 진행하지 않으므로 이 점 유의하시어 문서제출 이전에 user fee를 납부하여 주시기 바랍니다. (*User fee납부는 Device Facility User Fee (DFUF) website에서만 가능합니다)
이와 관련된 자세한 사항은 아래의 링크를 참조하여 주시기 바랍니다.
https://userfees.fda.gov/OA_HTML/furls.jsp?legalsel=2&ref.
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