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

 
• By Tina Tan

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.

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.

Removing the onerous task of stability testing was one of the key objectives of the Regulatory Task Force, a joint...

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• By Marion Webb

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• By Natasha Barrow

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• By Ashley Yeo

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• By Ivor Campbell

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• By Shubham Singh

The timing aligns with Medtronic’s plan to spin off its $2.8bn diabetes unit, now named MiniMed. As a standalone entity, MiniMed will be more responsive to competition, regulatory shifts, and the diabetes technology needs of healthcare systems.