Do I Need an Australian Sponsor for My Medical Device?

If you’re an overseas manufacturer looking to sell your medical device or IVD in Australia, the short answer is almost certainly yes: you need an Australian Sponsor. But what exactly does that mean, what are they responsible for, and what happens if you don’t have one? This guide answers all of it plainly.

The Short Answer: Yes, Almost Always

Under the Therapeutic Goods Act 1989, overseas manufacturers cannot supply medical devices or in vitro diagnostic devices (IVDs) in Australia unless an Australian Sponsor has been appointed and the device is included in the Australian Register of Therapeutic Goods (ARTG).

The only exceptions are a narrow set of device exemptions — mainly for custom-made devices, devices used solely for export, and a small number of devices covered by specific exemption orders. For the vast majority of commercial medical device supply into Australia, an Australian Sponsor is a mandatory legal requirement, not an optional formality.

Legal basis: The Australian Sponsor requirement is established under section 41BD of the Therapeutic Goods Act 1989. Supplying a device without an appointed Sponsor, or without ARTG inclusion, is a criminal offence under Australian law carrying significant penalties.

Who Exactly Needs an Australian Sponsor?

You need an Australian Sponsor if all of the following apply:

You are manufacturing the device outside Australia — meaning you do not have an Australian legal entity that manufactures the product
You intend to supply the device in Australia — including supplying to an Australian distributor, hospital, clinic, or direct to end users
Your device is classified as a medical device or IVD under Australian law — meaning it falls within the scope of the Therapeutic Goods Act 1989

It doesn’t matter whether you’re selling directly into Australia or supplying through a local distributor. It doesn’t matter whether you’re already CE Marked, FDA cleared, or certified under another major regulatory framework. If you’re an overseas manufacturer and your device is being supplied in Australia, you need a Sponsor.

What About Australian Manufacturers?

If you are an Australian manufacturer — meaning you have an Australian legal entity that manufactures the product — you are automatically considered your own Sponsor under the Act. You do not need to appoint a separate party. However, if you manufacture the device overseas and simply have an Australian office or distributor, that does not automatically make you an Australian manufacturer for regulatory purposes. The TGA looks at where the device is actually manufactured, not where your business is incorporated.

What if My Distributor is Australian?

Your Australian distributor can act as your Sponsor — and many do, particularly for smaller manufacturers or those entering the market for the first time. However, there are meaningful practical reasons why many manufacturers choose an independent professional Sponsor instead, which we cover in detail in our guide to choosing an Australian Sponsor.

What Does an Australian Sponsor Actually Do?

The Sponsor’s role goes well beyond filling out paperwork. Under Australian law, the Sponsor takes on a defined set of regulatory responsibilities on behalf of the overseas manufacturer. Understanding what those responsibilities are is important — both for choosing the right Sponsor and for understanding the ongoing obligations of the arrangement.

Before and During ARTG Application

Submitting Manufacturer Evidence (ME) to the TGA on the manufacturer’s behalf — this is the conformity assessment documentation (such as your EU MDR Notified Body certificate) that underpins the application
Preparing and submitting the ARTG inclusion application through the TGA’s e-Business portal
Ensuring device labelling and instructions for use meet Australian requirements, including displaying the Sponsor’s name and address
Preparing the Australian Declaration of Conformity with the Essential Principles
Managing all TGA communications during the review period, including responding to requests for additional information and coordinating audit responses

After ARTG Inclusion — Ongoing Obligations

Maintaining currency of Manufacturer Evidence — if your EU MDR Notified Body certificate expires or is suspended, the TGA must be notified and the ME updated
Adverse event and incident reporting — the Sponsor is required to report serious adverse events and near incidents to the TGA within defined timeframes
Managing any TGA-initiated market actions, recalls, or safety alerts in Australia
Updating ARTG entries when device changes occur that affect the listing
Making technical documentation available to the TGA on request, typically within 5 business days for Class I devices and 2 business days for higher-risk classes
Ensuring the manufacturer’s name and address appearing on device labels remains accurate

⚠ Watch out: The Sponsor’s obligations under Australian law do not end when the device is approved. They continue for the entire lifecycle of the product on the Australian market, including after any distribution arrangements change. This is why choosing a Sponsor who genuinely understands your device and your documentation is so important.

What Happens if You Supply Without an Australian Sponsor?

Supplying a medical device in Australia without an appointed Sponsor and valid ARTG inclusion is a breach of the Therapeutic Goods Act 1989. The consequences are serious:

Civil penalties of up to AUD 5 million for corporations (or 3x the benefit obtained, whichever is greater)
Criminal penalties for individuals, including fines and potential imprisonment for serious or repeated offences
TGA market actions including product recalls and stop-supply orders
Reputational and commercial consequences including damage to distributor relationships and difficulty obtaining future TGA approvals

The TGA actively monitors for non-compliant supply, including through post-market surveillance activities and complaints from industry participants. Overseas manufacturers who assume the Australian market is low-risk from an enforcement perspective underestimate the TGA’s reach.

✔ Practical tip: If you are currently supplying in Australia and are uncertain whether your Sponsor arrangements or ARTG listings are current and compliant, a compliance review is worth doing before the TGA raises the issue. Practical RA can assess your current position and identify any gaps.

The Three Ways to Fulfil the Sponsor Requirement

In practice, there are three ways overseas manufacturers arrange their Australian Sponsor:

Option 1: Your Australian Distributor Acts as Sponsor

This is common, particularly for manufacturers entering Australia for the first time or with a single distribution partner. The advantage is simplicity — your distributor already has an Australian presence and a commercial interest in getting your product listed. The disadvantage is dependency: if your distribution relationship changes, your ARTG listing is tied to that distributor, and changing Sponsors involves a formal TGA transfer process. Your distributor’s label also appears on the device, which may not align with your branding preferences.

Option 2: You Establish Your Own Australian Legal Entity

Some manufacturers with significant Australian market ambitions establish an Australian subsidiary or branch office, which then acts as the Sponsor. This gives you full control of your regulatory affairs in Australia and removes dependency on a third party. It is, however, a significant commercial and operational investment — with costs, compliance obligations, and management overhead that may not be justified unless Australia represents a meaningful proportion of your revenue.

Option 3: An Independent Professional Sponsor

An independent regulatory firm appointed as Sponsor provides a stable, commercially neutral regulatory arrangement that doesn’t depend on any single distributor relationship. You retain the flexibility to work with multiple distributors, change distribution arrangements, or enter direct supply arrangements, all without affecting your ARTG listings. The Sponsor’s name appears on labelling rather than a distributor’s, which can be preferable from a branding and competitive standpoint. For manufacturers planning a serious, long-term Australian market presence, independent professional Sponsorship is increasingly the preferred model.

✔ Practical tip: If you are working with, or planning to work with, multiple Australian distributors, or if you anticipate your distribution arrangements may change, an independent professional Sponsor is almost always the better structural choice. The cost of changing Sponsors after the fact, including relabelling and TGA transfer administration, generally exceeds the cost of getting the structure right from the start.

Is Your Product Actually a Medical Device Under Australian Law?

Before worrying about the Sponsor requirement, it’s worth confirming your product is actually regulated as a medical device or IVD in Australia. The TGA’s scope of regulation is broadly similar to the EU and US frameworks, but there are differences.

Under the Therapeutic Goods Act 1989, a medical device is defined as any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used for human beings for a medical purpose. The intended purpose as stated by the manufacturer is the primary determinant of whether a product is considered a device.

Products that are medical devices in the EU are generally also medical devices in Australia. However, some categories require specific attention: software products may be classified differently from their EU equivalents, particularly following Australia’s 2024 updates to software classification rules; combination products involving drugs and devices may be regulated differently; and some products classified as IVDs in Australia may be regulated as research-use-only or general laboratory products elsewhere.

Not sure if your product needs TGA registration? The TGA provides an online ‘Is my product a medical device?’ tool, and Practical RA can provide an assessment as part of initial discussions — at no charge.

Getting Started: What to Do Next

If you’ve established that your product is a medical device or IVD under Australian law, and you don’t yet have an Australian Sponsor in place, here’s what the initial process looks like:

Confirm your Australian device classification — this may differ from your EU MDR or FDA classification and needs to be verified before an ARTG application can be prepared
Assess your existing regulatory approvals — CE Marking under EU MDR 2017/745, FDA clearance, and MDSAP certification can all be leveraged to support an ARTG application under the abridged pathway
Choose your Sponsor structure — distributor, own entity, or independent professional Sponsor — based on your commercial model and long-term Australian market plans
Begin the Sponsor appointment and Manufacturer Evidence submission process — ME submission to the TGA is the first formal regulatory step and carries no TGA fee
Prepare Australian-specific documentation — including the Declaration of Conformity, updated labelling, and any Australia-specific technical documentation gaps

For most overseas manufacturers with existing CE Marking, the path from initial assessment to ARTG application submission is achievable in 2 to 4 weeks with an experienced Sponsor. The TGA review period varies by device class, but Class I and Class IIa devices with current international approvals can typically achieve ARTG inclusion within 4 to 6 weeks of application submission.

Practical RA provides Australian Sponsor services for overseas manufacturers of medical devices and IVDs. We are a Melbourne-based boutique regulatory firm with active expertise across EU MDR, US FDA, and TGA requirements, meaning we understand your existing documentation and can assess your pathway to the Australian market efficiently. Initial assessments are provided at no charge. Contact our team or reach out to Tara directly at tara@practicalra.com to discuss your situation.

Ready to explore Australian market access? Contact Practical RA for a no-charge initial assessment of your device’s pathway to ARTG inclusion and what’s needed to appoint an Australian Sponsor.

Key Takeaways

Almost all overseas manufacturers supplying medical devices or IVDs in Australia must appoint an Australian Sponsor. It is a legal requirement under the Therapeutic Goods Act 1989, not optional
Supplying without a Sponsor and valid ARTG inclusion can result in significant civil and criminal penalties under Australian law
The Sponsor holds ongoing legal responsibilities throughout the product lifecycle including adverse event reporting, maintaining manufacturer evidence, and managing TGA market actions
There are three ways to fulfil the Sponsor requirement: use your Australian distributor, establish your own Australian entity, or appoint an independent professional Sponsor
Independent professional Sponsorship offers the most flexibility for manufacturers working with multiple distributors or planning long-term Australian market presence
If you hold CE Marking under EU MDR 2017/745, you are well-positioned for an abridged TGA pathway. Read our guide to CE Marking to TGA for the full detail