Posts in PMDA

Illustration depicting ATMP classification and market entry strategies in Japan.
by Stefan Sandström
September 2, 2024

Navigating the ATMP Landscape: What Qualifies as an ATMP and Business Opportunities in Japan

Advanced Therapy Medicinal Products (ATMPs) represent a rapidly evolving field in biotechnology, offering transformative therapeutic solutions […]
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Wide-format illustration depicting ISO 13485's impact on the medical device industry, with navy blue, sand, and pink colors, featuring medical devices, ISO certification logo, and subtle Japanese elements like cherry blossoms and Mount Fuji silhouette.
by Stefan Sandström
February 28, 2024

ISO 13485 in Japan – the Global Standard for Medical Device Quality

The medical device industry demands the highest standards of quality and safety for its poducts. ISO […]
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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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