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Relaxation of device stability testing rules in Japan will shorten approval lag

This article was originally published in SRA

Executive Summary

Companies seeking regulatory approval for their medical devices in Japan no longer have to submit stability testing data to establish the expiration period of the product unless the technologies are highly-specialised and novel. This move, which is 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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