Australia – Regulation of software based medical devices : Update

The Governor-General in Council has made regulations which delay the commencement of a number of medical device reforms in Australia. This delay reflects the challenges identified by the medical devices industry and healthcare professionals to redirect their efforts to regulatory changes as they have focussed on the COVID-19 crisis.

The delay will allow additional time for the Therapeutic Goods Administration (the TGA) to further consult with the medical device industry and health care professionals on guidance material and implementation details relating to the reforms…