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.
Overview:  Introduction Six-month review process priority registration expanded PMDA support innovative drug consultation early application feedback […]
An artistic graphic showing an overview of the Marketing Authorization Holder (MAH) system in Japan with icons representing approval processes, quality assurance, and post-marketing surveillance.
Understanding the MAH Japan System In Japan, the Marketing Authorization Holder (MAH) is central in the […]