What your Australian Sponsor is responsible for — and the questions to ask before appointing one.
For an overseas medical device manufacturer planning to enter the Australian market, appointing an Australian Sponsor is an important regulatory decision.
Under Australia’s medical device regulatory framework, an overseas manufacturer requires an Australian Sponsor to supply its medical devices in Australia. But the Sponsor’s role goes well beyond submitting an application to the Therapeutic Goods Administration (TGA) — the Australian Sponsor becomes the regulatory link between the manufacturer and the TGA, and assumes important ongoing responsibilities associated with the device in Australia.
Choosing the right Sponsor should therefore be considered part of your Australian market-entry strategy, not simply an administrative step.
What is an Australian Sponsor?
The Australian Sponsor is the Australian-based legal entity responsible for the medical device in Australia. For an overseas manufacturer, the Sponsor generally submits the application for inclusion of the medical device in the Australian Register of Therapeutic Goods (ARTG) and acts as the primary point of contact between the manufacturer and the TGA. The TGA specifically states that overseas manufacturers require an Australian Sponsor.
Importantly, a Sponsor is not simply a regulatory representative whose involvement ends when the ARTG inclusion is obtained — the Sponsor has ongoing regulatory responsibilities for the device while it is supplied in Australia.
What is your Australian Sponsor legally responsible for?
The Sponsor assumes significant responsibilities under Australia’s therapeutic goods legislation. These responsibilities continue after the device has been included in the ARTG.
ARTG applications and maintenance
The Sponsor is responsible for applying to the TGA for inclusion of the relevant kind of medical device in the ARTG, and must ensure that information associated with the ARTG entry remains accurate and current. An ARTG entry is specific to the relevant Sponsor, manufacturer and kind of medical device.
Communication with the TGA
The Australian Sponsor acts as an important regulatory contact between the TGA and the manufacturer. The Sponsor must be able to obtain information from the manufacturer and provide requested information to the TGA within applicable timeframes. This may include:
- Technical documentation
- Clinical evidence
- Instructions for Use
- Evidence supporting conformity assessment
- Information relating to complaints or adverse events
- Post-market information
- Other documentation requested by the TGA
This makes the working relationship between the Sponsor and manufacturer particularly important.
Post-market surveillance and vigilance
The Sponsor’s responsibilities do not stop once market access has been achieved. Sponsors have ongoing obligations relating to the safety, quality and performance of devices supplied in Australia. These can include:
- Monitoring complaints and safety information
- Reporting adverse events within required timeframes
- Responding to TGA requests for information
- Maintaining appropriate records
- Complying with conditions of ARTG inclusion
- Supporting investigations
- Communicating safety information
- Working with the manufacturer when corrective action is necessary
- Undertaking recalls or other market actions where required
The Sponsor therefore needs systems capable of managing regulatory obligations throughout the entire Australian lifecycle of the device.
The Sponsor needs access to your regulatory documentation
An Australian Sponsor does not necessarily need to physically hold every element of the manufacturer’s technical documentation at all times. However, the Sponsor must be able to obtain required information from the manufacturer and provide it to the TGA when requested.
This means the manufacturer-Sponsor relationship needs effective processes for:
Document access
Who holds the technical documentation, and how quickly can it be provided?
TGA requests
Who reviews and prepares responses when the TGA requests information?
Regulatory changes
How will the manufacturer inform the Sponsor of changes to the device, intended purpose, certification, labelling or manufacturing arrangements?
Post-market issues
How will complaints, adverse events, safety signals and corrective actions be communicated?
Recalls
Who is responsible for each activity if an Australian recall or other market action becomes necessary?
These responsibilities should be clearly established before the Sponsor relationship begins.
Choosing the right Australian Sponsor
Selecting an Australian Sponsor is a critical step in your market entry strategy and should be based on more than cost or convenience. The Sponsor becomes your ongoing regulatory representative in Australia and plays a key role in maintaining your ARTG inclusion, managing TGA interactions and supporting post-market obligations.
When evaluating potential Sponsors, manufacturers should consider:
- Demonstrated experience with TGA medical device regulation
- Responsiveness and communication processes
- Capability to manage ongoing ARTG and post-market obligations
- Transparency in regulatory decision-making and reporting
- Systems for handling complaints, adverse events and recalls
- Ability to support regulatory changes and product lifecycle updates
- Clarity of responsibilities between manufacturer and Sponsor
- Long-term partnership approach rather than transactional support
A strong Sponsor relationship should provide regulatory confidence, not just market access.
How RQSolutions supports manufacturers
RQSolutions acts as an Australian regulatory partner for overseas medical device manufacturers, supporting both initial market entry and ongoing compliance. We work with manufacturers to:
- ct as Australian Sponsor where required
- Manage ARTG applications and maintenance
- Coordinate TGA communications and requests
- Support post-market surveillance and regulatory obligations
- Ensure ongoing compliance across the product lifecycle
- Provide clear, responsive regulatory support aligned with commercial goals
Our focus is on building long-term regulatory stability in the Australian market, not just achieving initial approval.
This article provides general regulatory information and is not intended to constitute legal or regulatory advice. Regulatory requirements should be assessed in relation to the particular device and circumstances.