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Japan's relaxing of device stability testing rules will shorten device lag

This article was originally published in Clinica

Executive Summary

Companies that are seeking Japanese regulatory approval for their medical devices no longer have to submit stability testing data used to establish the expiration period of the product, unless the technologies are highly-specialised and novel. This move, much-welcomed by industry, removes one of the biggest hurdles in Japan's notoriously convoluted regulatory system and is expected to significantly shorten the country's problematic device lag, the delay in approval of new medical devices between Japan and the US/Europe.

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