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Japanese trailblaze with GHTF (Global Harmonisation Task Force) product approval format

This article was originally published in Clinica

Executive Summary

The Japanese Ministry of Health, Labour and Welfare is trialling an internationally agreed format for technical documentation used on the submission of application for new or improved medical devices. The new format has been developed by the Global Harmonisation Task Force. The MHLW's one-year pilot-study began on February 1 and the European medical device industry association, Eucomed, says it supports the ministry in "encouraging device manufacturers active in Japan to participate in this pilot study".

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