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Sponsors

Overview​

The sponsor is the Australian-based legal entity that takes regulatory responsibility for a medical device supplied in Australia. Every medical device in the ARTG must have a sponsor. The sponsor is the TGA's primary point of contact in Australia — they are responsible for applying for ARTG inclusion, maintaining compliance over the life of the product, and reporting any issues. For overseas manufacturers, the sponsor is an essential and legally required intermediary.

Who Can Be a Sponsor?​

A sponsor must be either:

  • An Australian citizen or permanent resident, or
  • An incorporated body conducting business in Australia

A foreign company without an Australian presence cannot be a sponsor. Overseas manufacturers must appoint an Australian entity to act as their sponsor. This can be:

  • A dedicated regulatory affairs company
  • An Australian distributor
  • A subsidiary or related Australian company
  • An individual regulatory consultant (if a resident)

Each ARTG entry is unique to the sponsor, the manufacturer, and the kind of device. If a manufacturer wants to supply their device through multiple distributors in Australia, each distributor acting as sponsor needs their own ARTG entry — they cannot share one.

Core Sponsor Obligations​

1. Apply for ARTG Inclusion​

Only a sponsor can apply to include a medical device in the ARTG. The sponsor must ensure that before lodging an application:

  • The device genuinely meets the definition of a medical device
  • The correct device class has been determined
  • Appropriate manufacturer evidence (conformity assessment) has been accepted by the TGA (for Class IIa and above)
  • The application contains accurate and complete information

2. Be the TGA's Primary Contact​

The sponsor is the regulatory point of contact in Australia. All TGA communications about a device — requests for information, audit notices, adverse event follow-ups — go to the sponsor. The sponsor must be responsive and must obtain information from the manufacturer when the TGA requests it, within specified timeframes.

3. Report Adverse Events​

Sponsors are legally required to report adverse events and near adverse events to the TGA through the IRIS reporting portal. This is a non-delegable obligation. Even if it is the manufacturer who investigates the event, the reporting obligation sits with the Australian sponsor. Timeframes for reporting vary depending on the severity of the event.

👉 Adverse Event Reporting

4. Manage Recalls and Field Safety Actions​

If a device needs to be recalled or a field safety corrective action is required, the sponsor is responsible for coordinating and executing the action in Australia. This includes notifying affected customers, maintaining distribution records to facilitate the recall, and reporting progress to the TGA.

👉 Recalls and Field Safety

5. Maintain Distribution Records​

Sponsors must keep distribution records sufficient to enable an effective recall. The TGA expects sponsors to be able to identify where every batch of a device has been supplied, to whom, and in what quantities.

6. Keep Manufacturer Evidence Current​

The sponsor is responsible for ensuring that the manufacturer's conformity assessment certificates remain current and valid. If a certificate is suspended, revoked, or lapses, the sponsor must notify the TGA and the device cannot continue to be supplied until the situation is resolved.

7. Pay Annual Charges​

There are annual charges associated with maintaining ARTG entries. The sponsor is responsible for payment. Failure to pay can result in cancellation of the ARTG entry.

Written Agreement with the Manufacturer​

Sponsors must have a written agreement with the manufacturer that sets out how regulatory information will be exchanged. The agreement must ensure the sponsor can obtain the following from the manufacturer when requested by the TGA, within 20 working days:

  • Evidence of conformity with the Essential Principles
  • Adverse event investigation results
  • Information about design or manufacturing changes
  • Post-market surveillance data

The TGA does not provide a standard template for this agreement — it is a commercial and legal arrangement between the sponsor and manufacturer.

When a Health Professional Becomes a Sponsor​

If a health professional imports a medical device directly from an overseas supplier for use in their clinical practice — even for a single patient — they may become the sponsor of that device under Australian law. This means they take on all sponsor obligations, including ensuring the device is included in the ARTG (or covered by a valid exemption such as the Special Access Scheme). Health professionals who are sponsors must fulfil the manufacturer's warranty and arrange servicing and maintenance where required.

Official Sources​