Australia
Our expertise in Australia market access will accelerate your time to market.
We support seamless market access
As an MD or IVD manufacturer, you know that Australia requires local regulatory compliance, and the requirements differ significantly depending on classification. In Australia, products must be registered with the TGA, conform to Essential Principles, hold appropriate conformity assessment evidence, bear UDI labels compliant with AusUDID, need an MDSAP-compliant QMS, and need a local Sponsor. At the same time, higher-risk devices have additional rules and requirements. A clear regulatory strategy, identifying risks, understanding document requirements, and transparent timelines are necessary. If you cannot do so, your market access can be delayed.
We use local expertise to guide clients through the regulatory system and act as your official Sponsor for ARTG. We take care of end-to-end matters, ensuring a smooth process and clear timelines.
Manufacturers represented across 40 markets
Discover how we can help:
Australia Market Access (TGA ARTG Listing)
We manage classification, technical dossier preparation, local product testing, and clinical or clinical-exemption pathways to secure your device's TGA registration.
Australia Sponsor Services
We help manage an Australian Sponsor who handles registrations, post-market surveillance, and adverse event reporting, liaises with the TGA, and maintains your legal credentials on official documents.
Misclassifying devices, delaying submissions, or missing UDI and MDSAP audit requirements in Australia can delay ARTG approval.
By providing regulatory clarity, complete documentation, Sponsor continuity, and compliance planning for audits and vigilance, we streamline your market approval, saving you time, reducing risk, and ensuring sustained regulatory alignment.
Take advantage of our practical approach for market approval in Australia.
Couldn't find your question?
Can we combine Australia and New Zealand?
In the past, both countries could be combined. Nowadays, their regulatory frameworks differ significantly. Australia requires a TGA-appointed Sponsor for ARTG inclusion, while New Zealand requires a local Sponsor for WAND notifications. New Zealand has less stringent requirements; ask us for more details.
What is UDI compliance in Australia?
Australia introduced UDI requirements in March 2025, with phased deadlines: Class III/IIb by July 2026 and Class IIa/I by mid-2027, requiring both label marking and data submission to AusUDID.
How long does TGA ARTG Listing take?
For devices based on recognized overseas conformity evidence, ARTG inclusion can take a few weeks; other applications, especially high-risk devices, extend timelines to 4–12 months.
Do I need a sponsor for Australia and New Zealand separately?
Yes, both countries require local Sponsors. In Australia, the Sponsor must be based locally and is legally responsible for the device’s inclusion on the ARTG. In New Zealand, WAND notifications also require a local Sponsor, though the process is less formal and does not imply market authorization. A single entity cannot act as a Sponsor in both countries without legal presence.