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CATEGORY: REGULATORY PATHWAYS
ARTG (Australian Register of Therapeutic Goods)
The Australian register of all therapeutic goods (medicines, medical devices, biologicals) approved for supply in Australia. All medical devices must be included on the ARTG before they can be legally supplied. Managed by the TGA.
Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy
WHEN IT APPLIES
The Australian Register of Therapeutic Goods (ARTG) lists therapeutic goods—including medical devices—that can be legally supplied in Australia under TGA oversight.
PROCESS / STEPS
- Appoint an Australian sponsor.
- Compile conformity assessment evidence for the class.
- Apply for ARTG inclusion.
- Maintain entries and report adverse events/recalls.
EXAMPLES
- Export-only or unapproved devices generally cannot be supplied domestically without ARTG inclusion or a specific exemption pathway.
RELATED GUIDES & TOOLS
SOURCES
Track regulatory signals related to ARTG (Australian Register of Therapeutic Goods) across 27 authorities in real time.
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