Cracking the Code: Japan's PMD Act & QMS Requirements

Medical Device Global Market Access

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 medical device in Japan? • What are the key "gaps" between Japan's QMS requirements and ISO 13485? • How has the March 25, 2024, deadline impacted QMS compliance for Japan? • What is a "Medical Device File" and how does it differ from an EU Technical File? • Who gets audited during a Japanese QMS conformity assessment? • What are the specific document and record retention rules under Ordinance 169? • Why is the Marketing Authorization Holder (MAH) so vital for regulatory success in Japan? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email [email protected] for tailored support.