What's new
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September 18, 2026
Devices
New
SaMD page updated (guide revised, seminar videos and materials published, consultation schedule updated)
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September 17, 2026
Drug
IVD
New
CDx approved for identifying eligible patients (Updated)
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September 17, 2026
Drug
New
English Translation of Review Report: Opsumit (Partial Change Approval)
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September 17, 2026
Devices
New
List of Approved Medical Devices: April 2004 to December 2025
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September 10, 2026
Devices
English Translation of Review Report: remedē System
