Latest / Medical Device Global Market Access
Cracking the Code: Japan's PMD Act & QMS Requirements
This episode provides a focused guide to Japan's medical device regulations. We explore the relationship between the overarching PMD Act and the detailed QMS requirements of MHLW Ordinance 169. Learn about the crucial 2021 harmonization with ISO 13485:2016, the key differences that remain, and how the Japanese audit process presents unique challenges for foreign manufacturers, including an expanded audit scope and specific documentation demands. Key Questions: • What is the relationship between Japan's PMD Act and MHLW Ordinance 169? • Is my ISO 13485:2016 certification enough to sell my…
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