Medical device notices and standards orders
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Legislation on this site should be accessed from the official versions. Occasionally, these instruments are amended and replaced or new ones are made.
Medical device notices
- Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023 - external site
Declares that certain articles are not medical devices for the purposes of the Therapeutic Goods Act 1989 (the Act). - Therapeutic Goods (Medical Devices - Specified Articles) Instrument 2020 - external site
Specifies a particular class of non-sterile personal protective equipment and safety apparel to be medical devices under subsection 41BD(2B) of the Act.
Medical device determinations
- Therapeutic Goods (Medical Devices - Information that Must Accompany Application for Inclusion) Determination 2018 - external site
Determines the kind and form of information that must accompany an application for a kind of medical device to be included in the ARTG. - Therapeutic Goods (Overseas Regulators) Determination 2018 - external site
Specifies the specific entities that are determined to be an overseas regulator for the purposes of subsection 41BIB(1) of the Act. - Therapeutic Goods (Excluded Goods) Determination 2018 - external site
Specifies products that are excluded goods for the purposes of the Act. - Therapeutic Goods (Excluded Goods) Amendment (Personalised Medical Devices) Determination 2021 - external site
Specifies certain kinds of lower risk devices excluded for the purposes of the Act. For example, spectacle frames and medicament trays. - Therapeutic Goods (Excluded Goods) Amendment (Borderline Products - COVID-19) Determination 2021 - external site
Specifies certain borderline products excluded for the purposes of the Act. For example, cleaning and sanitary products.