In November 2014, Japan introduced the Pharmaceutical and Medical Device Act (PMD Act), which made significant changes to the country's medical device registration process. It also changed the way manufacturers meet quality management system requirements. While Japan's quality regulations are similar to ISO 13485, there are some important differences you should be aware of if you want to sell your medical device in Japan.
In this white paper produced by Emergo's office in Tokyo, we answer your biggest questions about QMS requirements in Japan, including:
Learn all this and more in this 8-page white paper.
Medical Device Approval Process in Japan
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Japan's New Pharmaceutical and Medical Devices Act (PMD Act)
All documents listed below were published by the Ministry of Health, Labour and Welfare (MHLW) or the Pharmaceutical and Medical Devices Agency (PM
read moreJapan is the largest market for medical devices in Asia. Though Japan has less than one-tenth (1/10) the population of China, the Japanese spend mo
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