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CATÉGORIE: REGULATORY PATHWAYS

ARTG (Registre australien des produits thérapeutiques)

Le registre australien de tous les produits thérapeutiques approuvés pour la fourniture en Australie.

Last reviewed 2026-08-05 · Reviewed by MedFlux Editorial Board · Editorial policy

Expanded process notes below are currently maintained in English; the short definition above is localized. See our 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

  1. Appoint an Australian sponsor.
  2. Compile conformity assessment evidence for the class.
  3. Apply for ARTG inclusion.
  4. 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

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TERMES CONNEXES

Évaluation de conformité