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MFDS (South Korea)
NOTICE
체외진단의료기기 허가·신고·심사 등에 관한 규정 일부개정고시(안) 행정예고(공고 제2026 - 508호)
Published: 10/29/2026Detected: 10/29/2026

Summary preview

Administrative notice for a proposed partial amendment to the MFDS regulations governing authorization, notification, and review processes for in vitro diagnostic medical devices.

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manufacturing
quality
clinical
safety
labeling
#MFDS
#in vitro diagnostic
#IVD medical device
#authorization
#notification

Official Source Document
Source Verified

Access the original document directly from MFDS.

View Official Document

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