[Home](/)/[Resources](/resources)/Australia TGA Medical Device Registration AustraliaGlobalRegulation guide # Australia TGA Medical Device Registration The Therapeutic Goods Administration classifies medical devices across a five-tier risk scale — Class I, IIa, IIb, III, and Active Implantable Medical Devices — with conformity assessment depth scaling accordingly, all converging on Australian Register of Therapeutic Goods (ARTG) inclusion as the market-access endpoint. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Faustralia-tga-medical-device-registration) At a glance Regulator TGA Classes I, IIa, IIb, III, AIMD Endpoint ARTG inclusion Implant retention 15 years minimum ## Classification and conformity routes ### Class I — self-assessment Lowest-risk devices route through self-assessment plus ARTG inclusion, without requiring TGA conformity assessment review. ### Class IIa — conformity assessment + ARTG Low-medium risk devices require conformity assessment evidence before ARTG inclusion, a step up from Class I's pure self-assessment. ### Class IIb — conformity assessment + TGA review + ARTG Medium-high risk devices add a direct TGA review step on top of conformity assessment, before ARTG inclusion is granted. ### Class III / AIMD — full TGA assessment The highest-risk categories — Class III devices and Active Implantable Medical Devices — require full TGA conformity assessment before ARTG inclusion, the most demanding route in the Australian system. ### IVDs — separate risk-based scale In-vitro diagnostic devices follow their own risk-based classification (Classes 1–4) rather than the general device scale, with ARTG inclusion still the common endpoint. ## Registration workflow 01 Determine classification (Class I, IIa, IIb, III, or AIMD) under TGA's risk-based framework. 02 Prepare technical documentation — a design dossier and technical file — appropriate to the classification. 03 Conduct conformity assessment where the classification requires it (IIa and above). 04 Submit the ARTG inclusion application as the sponsor. 05 Complete TGA review and approval, with the review depth scaling by classification. 06 Place the device on the market carrying its ARTG number once inclusion is granted. 07 Maintain post-market surveillance — adverse event reporting and ongoing PMS reports — for the device's lifetime on the register. ## Record retention 01 Non-implantable medical device records: minimum 5 years 02 Implantable medical device records: minimum 15 years 03 General retention principle: device lifetime plus 2 years, subject to the category-specific minimums above ## Frequently asked questions ### What does ARTG inclusion actually mean? The Australian Register of Therapeutic Goods (ARTG) is TGA's public register — inclusion means the device has completed the classification-appropriate conformity assessment and TGA review process and is authorized for supply in Australia. The ARTG number is what appears on the marketed device and in public search. ### How long do I need to retain medical device records? Generally, device lifetime plus 2 years, with category-specific minimums: at least 5 years for non-implantable devices, and at least 15 years for implantable devices — the longer minimum reflecting the extended real-world risk window implants carry. ### Can existing EU MDR or US FDA clearance support a TGA application? Existing international conformity assessment evidence can often support a TGA application, but the specific evidentiary requirements depend on the device's Australian risk classification — treat prior CE/MDR or FDA clearance as potentially reusable supporting evidence, not an automatic substitute for the Australian classification-specific requirements. ### Is post-market surveillance a one-time filing or an ongoing obligation? Ongoing. Sponsors must maintain post-market surveillance reporting and adverse event reporting for as long as the device remains on the ARTG — this is a continuing obligation tied to market presence, not a single post-launch report. **Disclaimer:** Educational resource only. Regulatory requirements change and vary by product category. Consult an accredited test laboratory or qualified compliance engineer before making certification decisions. 🇦🇺 Australia roadmap for your product Every standard, document, and test that applies — free, no account required. 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