Japan’s IVD sector remains highly structured and closely governed, benefiting from a mature healthcare infrastructure and […]
Illustration depicting ATMP classification and market entry strategies in Japan.
Advanced Therapy Medicinal Products (ATMPs) represent a rapidly evolving field in biotechnology, offering transformative therapeutic solutions […]
Seminar date: May 16, 2024   Thanks to its size, technological advancements, and commitment to innovation, […]
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.
The medical device industry demands the highest standards of quality and safety for its poducts. ISO […]
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 […]