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- ISO13485 In Vitro Diagnostic/ Medical Devices
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- ISO 27001 Information Security
- ISO 27701 Privacy Information Management
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- ISO 15378 Primary Packaging Materials
- ISO 22000 Food Safety
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ICMC (International Certification Management Center Co., Ltd.)
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Medical Devices FDA
icmcert@naver.com
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Medical Devices FDA
[FDA] UDI(Unique Device Identification)의 최종 안
- Admin Hits:549
- 2019-08-14 19:50:00
현재 미국에서 적용하고 있는 UDI에 대한 자료입니다.
하기와 같이 확인이 가능합니다.
1. 제품 특성(Implant 등)에 따른 적용 방안
2. UDI rule 소개 (구성, 표시, 제외요구사항 및 데이터베이스)
3. 실제 라벨 예시 (포장단위별 라벨 및 바코드 예시)
FDA에서 UDI 관련 공지한 Final Report를 첨부와 같이 확인 가능합니다.
* 출처 : FDA Food and Drug Administration office of Policy & Planning
* 첨부 : Unique Deivce Identification Final Report
하기와 같이 확인이 가능합니다.
1. 제품 특성(Implant 등)에 따른 적용 방안
2. UDI rule 소개 (구성, 표시, 제외요구사항 및 데이터베이스)
3. 실제 라벨 예시 (포장단위별 라벨 및 바코드 예시)
FDA에서 UDI 관련 공지한 Final Report를 첨부와 같이 확인 가능합니다.
* 출처 : FDA Food and Drug Administration office of Policy & Planning
* 첨부 : Unique Deivce Identification Final Report
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