Japan loosens stability testing requirements for devices

02/11/2013 | Clinica (subscription required)

Japan will no longer require medtech companies to include stability testing data in order to get approval for devices after a Regulatory Task Force agreed the requirements could be eliminated in most cases. The task force is comprised of the country's Ministry of Health, Labour and Welfare, as well as medical device industry representatives. The move is meant to alleviate the delay in medical device approval in Japan, but certain devices still require the data, including those that contain certain raw materials, biological products and radioactive material.

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