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East vs West: how Japan’s new auditing system differs from the EU

This article was originally published in Clinica

Executive Summary

What are the main challenges for companies when it comes to demonstrating compliance with Japanese medical device requirements, and particularly those that are different to requirements in markets such as the EU? Amanda Maxwell spoke with Eiko Tabuchi of T?V S?D Japan to find out how regulation of medical devices in Japan compares with the EU since the latest Pharmaceutical and Medical Device Act came into force at the end of 2014






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