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ISO SYSTEM
- ISO13485 In Vitro Diagnostic/ Medical Devices
- ISO 22716 Cosmetics
- ISO 27001 Information Security
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- ISO 22000 Food Safety
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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] PMA Approvals 이란?
- Admin Hits:663
- 2016-11-04 19:19:00
Class III (Premarket Approval, PMA)
의료기기 중 가장 위험도가 높게 평가되는 의료기기로,
‘시판 전 승인’ 절차를 거쳐야 하며 통상 PMA Submission이라 불리웁니다.
- Class III(PMA)의 심사 과정
‘시판 전 승인’ 신청 서류는 아주 복잡한 단계를 거칩니다.
서류 심사와 제조시설 및 임상시험 실시기관에 대한 직접 방문을 통한 감사를 포함하여 FDA, CDRH(의료기기 및 방사선 보건국, Center for Devices and Radiological Health)의 여러 부서가 참여하여 의료기기에 대한 안전성 및 유효성, 제조시설에 대한 확인(QSR), 임상시험 실시에 대한 적합성 등 모든 것을 확인합니다.
이와 같이 FDA 홈페이지 내에서 PMA의 일반 안내 및 기본 정보 확인이 가능하십니다.
링크 : http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm
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