Cochlear calls for low risk health apps to be exempt from TGA register

Sydney Morning Herald

3 July 2020 - Hearing implant giant Cochlear has called for some low risk health apps to be exempt from the therapeutic goods register, joining a push by medtechs for greater certainty on the regulation of medical and healthcare software.

Over the past two years regulators have been grappling with the oversight of medical software amid a boom in healthcare apps, clinical products and health trackers.

Last year a new set of requirements was established that categorised software based on the level of risk the product poses to patients. In June, the government flagged it would delay the rollout of new medical device regulation, including for software, until next year due to COVID-19.

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Michael Wonder

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Michael Wonder

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Regulation , Australia , Device , Software