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The Health Pod
Episode 13: Japan Medical Device Market – Healthcare Apps and Software as a Medical Device (SaMD)
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We frequently receive regulatory questions about the increasing number and variety of healthcare apps being developed in Japan and elsewhere in the world. From a regulatory point of view, the most important issue is whether a particular app will be treated as a regulated medical device under the Pharmaceutical and Medical Devices Act (PMD Act). In the first installment of our “Japan Medical Devices Law Podcast” series, Ryosuke Tateishi, our regulatory and compliance partner, Mami Ohara, an industry specialist with experience in corporate transactions, and Fei Zhou, our finance and investment specialist, take a closer look at recent developments and introduce the regulatory landscape surrounding healthcare apps in Japan.

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