The ARTG route
ARTG inclusion before supply, the local sponsor requirement, and TGA's post-market monitoring — with the obligations you need.
Free field guide · PDF
Australia TGA: Medical Device Registration2026 Field Guide
The ARTG route, the UDI launch, and the software tightening — with the registration practice you need.
- UDI live
- 1 Jul 2026
- AusUDID window
- 30 days
- CDSS tightening
- 1 Nov 2026
Sourced from TGA and verified 2026 publications.
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What's inside
Five pages, zero fluff
Every figure in this guide traces to a named source — TGA and verified 2026 publications.
The UDI launch
UDI mandatory from 1 July 2026 for Class IIb/III — 30-day AusUDID submission window, ARTG linkage, and 2028 direct marking.
The software tightening
From 1 November 2026, F2026L01167 tightens the CDSS exemption — AI-enabled decision support can't use it, even in software you already use.
Sources & scope
- tga.gov.au, Software and artificial intelligence (AI).
- TGA, Complying with the Unique Device Identification timeframes V2.0 (May 2026).
- cliniccomply.com.au, TGA CDSS Changes 1 November 2026.
This guide is market-access intelligence, not regulatory or legal advice. TGA registration pathways, UDI timeframes, and exemption criteria change — professional review is required before business use.
Market Access Strategy Session
Australia on your 2026 roadmap? Start with the full picture.
A Market Access Strategy Session maps your TGA route — ARTG inclusion, sponsor readiness, and UDI compliance.
Professional review is required before business use.
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