Australian TGA Sponsor for Medical Devices and IVDs

Compliance Management Solutions acts as the official Australian TGA sponsor for overseas manufacturers of medical devices and IVDs. We support your ARTG inclusion, prepare your regulatory submissions, communicate directly with the TGA on your behalf, and carry the post-market work that comes with the role: post-market surveillance, adverse event reporting and ongoing compliance.

Talk to us about sponsorship Call +61 4 33 124 266

What an Australian sponsor is, and why you need one

A therapeutic good must be included in the ARTG before it can be supplied in Australia, and it is the sponsor who makes that application. The Therapeutic Goods Act 1989 defines the sponsor as the person who imports, exports or manufactures the goods, or arranges for someone else to. In practice the party that imports the goods into Australia is the sponsor, and it is the sponsor who applies to the TGA, so an overseas manufacturer without an Australian presence reaches the market through an Australian sponsor, and the ARTG entry is held in that sponsor's name.

That makes the sponsor more than a postal address. It is the party the TGA holds accountable for the device once it is on the market, which is why the choice of sponsor matters as much as the application itself.

What we do as your sponsor

Getting on the ARTG

Official Australian sponsor for your devices, so you can supply the Australian market without an Australian entity of your own.
Regulatory strategy and market access. Many devices can rely on an assessment already made by a comparable overseas regulator: EU notified bodies (under the EU MDR and IVDR), the US FDA, Health Canada, MDSAP auditing organisations, Japan's MHLW and PMDA, Singapore's HSA and UK approved bodies. We map your existing certificates to the Australian pathway.
ARTG inclusion support and regulatory submissions, including the manufacturer evidence your ARTG application depends on.
Direct communication with the TGA throughout assessment and after inclusion.

Staying compliant once you are on the market

Adverse event and vigilance reporting to the TGA within the statutory timeframes (below).
Post-market surveillance and post-market surveillance documentation.
Complaint handling systems and CAPA management, so issues are captured, investigated and closed.
Annual reporting obligations and technical documentation maintenance.
Regulatory correspondence with the TGA and continuous compliance support, for as long as you supply Australia.

What the TGA expects of a sponsor

The TGA's post-market guidance sets out what a medical device sponsor is responsible for once a device is on the market. Beyond adverse event reporting, these include:

Recalls and other market actions, conducted under the TGA's Procedure for Recalls, Product Alerts and Product Corrections (PRAC), which replaced the older Uniform Recall Procedure on 5 March 2025.
Access to information and samples. The sponsor should have written arrangements with the manufacturer to obtain further information when the TGA asks, usually within 10 to 20 working days.
Distribution records, kept for five or ten years after the last supply depending on the device class.
Annual charges for each ARTG entry and, where a product is not yet generating turnover, the Annual Charge Exemption declaration, made each year between 1 and 22 July.
Advertising that complies with the Therapeutic Goods Advertising Code.
Notifying the TGA when a conformity assessment certificate lapses.

Post-market reporting deadlines

These are the timeframes a medical device sponsor works to under the TGA's adverse event reporting guidance. They run from when the sponsor becomes aware of the event, which is why the reporting line between your complaint handling and your sponsor has to be agreed before launch, not after the first incident.

Event	Initial report due
Represents a serious threat to public health	48 hours
Led to death or a serious deterioration in health	10 days
Might have led to death or a serious deterioration in health	30 days
Follow-up reports while the investigation is open	At least every 30 calendar days
Final report	Within 120 calendar days of the initial report

Only events that occur in Australia must be reported to the TGA, but records of overseas events involving devices supplied here should be available if the TGA asks for them.

Choosing who sponsors your device

A common arrangement is for a distributor to act as sponsor. It works while the commercial relationship holds. Because the ARTG entry is held by the sponsor, a manufacturer that wants to change distributor can find its market access tied up in the change of sponsor.

Whoever you appoint, agree at the start how complaints and adverse events reach the sponsor, who keeps which records, and what happens to your ARTG entries if the arrangement ends. A sponsor whose role is regulatory rather than commercial keeps those questions separate from your sales channels.

Changing sponsor

If you already have ARTG entries with another sponsor, they can be moved. The TGA's change of sponsor guidance sets out how it works:

The existing sponsor transfers its interest in the ARTG entries to the new sponsor.
The new sponsor is responsible for the entries from the moment the transfer takes effect, even before the TGA has updated its records, so post-market duties must be handed over on the same day.
The new sponsor notifies the TGA, which usually updates the ARTG entries within 10 working days.
There is no TGA fee for the notification, but a transfer that includes a medical device may need the manufacturer evidence to be provided again.

If you are considering a change of sponsor, talk to us about what is involved for your devices.

Medical devices, IVDs and medicines

We sponsor across all three. Medical devices are classified by risk from Class I through Class IIa and IIb to Class III. IVDs are medical devices under Australian law but have their own Class 1 to 4 classification, based on the health risk that an incorrect result would cause. Medicinal products follow a separate registration and listing framework, with manufacturing held to GMP; our pharmaceutical GMP and GDP experience supports sponsors on that side.

Unique Device Identification from 1 July 2026

The TGA's UDI requirements began on 1 July 2026, starting with higher-risk devices (Class IIb and Class III), with lower-risk devices and IVDs to follow over later years.

New Zealand

New Zealand is a separate system. Devices supplied there must be notified to Medsafe's WAND database by a New Zealand sponsor, and Medsafe states that organisations without a physical presence in New Zealand cannot be sponsors. Alongside Australian sponsorship, we provide Authorised New Zealand Agent services, including regulatory liaison with Medsafe and ongoing compliance management.

How it works

An initial conversation about your products, their classification and the markets you want to enter.
Regulatory strategy: a review of your existing certificates and technical documentation against the TGA pathway.
Regulatory submissions and ARTG inclusion, with direct communication with the TGA through to inclusion.
Ongoing sponsorship: post-market surveillance, adverse event reporting, complaint handling and regulatory correspondence, for as long as you supply Australia.

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Frequently asked questions

Do overseas manufacturers need an Australian sponsor?

Yes, in practice. Under the Therapeutic Goods Act 1989 the sponsor is the person who imports, exports or manufactures the goods, or arranges for that to be done, and it is the sponsor who applies to include the device in the ARTG. An overseas manufacturer without an Australian presence therefore supplies Australia through an Australian sponsor.

Can my distributor be my TGA sponsor?

It can, and many are. The point to weigh is that the ARTG entry sits with the sponsor, so if the distribution relationship ends, your market access moves with the change of sponsor. Whoever you appoint, agree at the start how complaints and adverse events reach the sponsor and what happens to your ARTG entries if the arrangement ends.

Can I change my TGA sponsor?

Yes. The TGA provides a change of sponsor process. The new sponsor becomes responsible from the moment the transfer takes effect, notifies the TGA, and the TGA usually updates the ARTG entries within 10 working days. There is no TGA fee for the notification, although a transfer involving a medical device may require the manufacturer evidence to be provided again.

What are the adverse event reporting deadlines for a medical device sponsor?

From when the sponsor becomes aware of the event: 48 hours for an event that represents a serious threat to public health, 10 days for an event that led to death or a serious deterioration in health, and 30 days for an event that might have led to death or serious deterioration. Follow-up reports are due at least every 30 calendar days and a final report within 120 calendar days of the initial report.

Do you act as sponsor for IVDs and medicines as well as medical devices?

Yes. Compliance Management Solutions acts as Australian TGA sponsor for overseas manufacturers of medical devices, in vitro diagnostic devices (IVDs) and medicinal products. IVDs are regulated as medical devices in Australia with their own Class 1 to 4 risk classification.

Is an Australian sponsor also my New Zealand sponsor?

No. New Zealand runs a separate system. Devices supplied there must be notified to Medsafe's WAND database by a New Zealand-based sponsor, and Medsafe states that organisations without a physical presence in New Zealand cannot be sponsors. Alongside Australian sponsorship, we provide Authorised New Zealand Agent services, including regulatory liaison with Medsafe.