We will have limited operations from 15:00 Wednesday 24 December 2025 (AEDT) until Friday 2 January 2026. Find out how to contact us during the holiday period.
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TopicA collection of information about the implementation of medical devices Unique Device Identification (UDI).
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SectionReport a problem or find information about safety, recalls and shortages.
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PageAustralia has rules on importing medicines and medical devices.
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PageIf you use counterfeit medicines or medical devices you are risking your health.
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PageAll implantable and active implantable medical devices must come with patient information materials.
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PageAs of May 2025, two HIV self-tests are approved for use in Australia, the Atomo HIV Self Test and the Panbio HIV Self-Test.