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Brave new world: how to navigate the new Japanese medical device regulatory landscape

This article was originally published in Clinica

Executive Summary

For more than 50 years, medical devices in Japan were regulated the same way as drugs. But all this changed at the end of last year when a new legislation came into force, enabling devices to finally have a separate regulatory route which would hopefully expedite their entry to market. Masanori Otake* discusses the three most significant changes how devices are regulated and advises on how to navigate the new landscape

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