Note
If you intend to rely on any legislation referred to on this website, you should access copies of the official versions. These instruments are amended from time to time and may, on occasions, be replaced or new instruments made.
Medical device notices
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LegislationThis Determination specifies a number of articles that are not medical devices for the purposes of the Therapeutic Goods Act 1989.
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LegislationThis Instrument specifies certain classes of articles that are considered medical devices for the purposes of the Therapeutic Goods Act 1989.
Medical device determinations
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LegislationThis Determination specifies the information that must accompany an application to include a medical device in the Australian Register of Therapeutic Goods (ARTG).
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LegislationThis Determination sets out overseas bodies which are overseas regulators of medical devices for the purposes of the Therapeutic Goods Act 1989.
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LegislationThis Determination specifies goods that are excluded from regulation for the purposes of the Therapeutic Goods Act 1989.
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LegislationThis legislation amends the list of goods excluded from regulation under Australia's therapeutic goods framework.
Medical device standards orders
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LegislationThe Medical Device Standards Order (Endotoxin Requirements for Medical Devices) 2018 establishes the endotoxin limits for medical devices to minimise risks associated with endotoxin contaminants and residues.
Conformity Assessment Standards orders
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LegislationThis Order constitutes an optional conformity assessment standard for specified quality management systems relating to the manufacture of medical devices.
Guidance on MDSOs and CASOs
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PageGuidance on the two key requirements of the conformity assessment procedures for medical devices that a manufacturer must implement
Product types
Page history
Changed page title and content updates.
Original publication.
Changed page title and content updates.
Original publication.