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Medical Devices / Regulatory Affairs / Submissions and Approvals

Australia Clarifies Criteria for Priority Reviews

Jan. 9, 2018

Australia’s Therapeutic Goods Administration issued new guidance on the priority review pathway for medical devices including IVDs.

The regulatory authority set three criteria that medical devices must meet in order to be considered in its “front-of queue” priority list: The new device’s intended use must be for the treatment of a serious health condition; the expectation must be for it to “fulfil a major or urgent unmet medical need”; and it must be associated with the use of breakthrough technology.

There is also an additional criterion for IVDs — the sponsor’s application should include a justification for how early market availability in the country will result in improved health of the Australian population.

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