Posts in Regulatory Compliance

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 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.
by Stefan Sandström
February 14, 2024

MAH Japan: A Strategic Guide for Navigating the System

Understanding the MAH Japan System In Japan, the Marketing Authorization Holder (MAH) is central in the […]
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