ARTG and the sponsor
Foreign manufacturers file through an Australian sponsor — Class I in 5–10 days, higher classes in 4–6 months.
Free field guide · PDF
Australia TGA Medical Device Registration2026 Field Guide
ARTG inclusion, the mandatory Australian sponsor, and the July 2026 UDI deadline.
- Class I inclusion
- 5–10 days
- Higher-class review
- 4–6 mo
- UDI deadline
- Jul 2026
Sourced from the TGA 2026–27 fee schedule and UDI regulations.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — the TGA 2026–27 fee schedule and UDI regulations.
Two 2026 deadlines
UDI compliance starts 1 July 2026 for Class III/IIb; the CDSS exemption tightens 1 November 2026.
The practical playbook
Shortened review for CE-approved devices, annual ARTG charges, and high-risk annual reporting.
Sources & scope
- TGA, cost recovery implementation statement 2026–27.
- Australian legislation F2026L00847, UDI explanatory statement.
- Morulaa, Australia medical device registration guide.
- MavenProfServ, medical devices registration in Australia.
This guide is market-access intelligence, not regulatory or legal advice. TGA pathways and fees are product-specific — professional review is required before business use.
Market Access Strategy Session
Australia on your roadmap? Start with the full picture.
A Market Access Strategy Session maps your TGA route — classification, sponsor selection, and ARTG inclusion.
Professional review is required before business use.
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