Posts in early application feedback

An illustration featuring a central origami figure in gold, symbolizing the concept of 'Software as a Medical Device' (SaMD) against a minimalistic background. The design merges technology and healthcare through an elegant origami representation.
by Stefan Sandström
February 14, 2024

SaMD and PMDA – Japan’s Fast Track Policies to Expedite SaMD Registration

Overview:  Introduction Six-month review process priority registration expanded PMDA support innovative drug consultation early application feedback […]
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