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Regulatory decisions & notices (medical devices & IVDs)

Regulatory decisions for medical devices & IVDs

Notices and advice for industry about medical devices & IVDs

2020 2019 2018


  • Exemption for coronavirus (COVID-19) medical devices
    27 February 2020: The Therapeutic Goods Act 1989 (the Act) provides that the Minister for Health (or his delegate) may exempt certain kinds of medical devices that are not included in the Australian Register of Therapeutic Goods from various provisions of the Act so that those devices can be made available urgently to deal with public health emergencies.