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类别: REGULATORY PATHWAYS
ARTG（澳大利亚治疗产品注册）
澳大利亚所有批准在澳供应的治疗产品（药品、医疗器械、生物制品）注册。所有医疗器械在合法供应前必须纳入ARTG。由TGA管理。
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
- 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（澳大利亚治疗产品注册） across 27 authorities in real time.
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