The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
If you intend to supply a medical device in Australia, you need to meet the definition of a Sponsor under the Therapeutic Goods Act 1989. These requirements include that you must be a recognised Australian-based legal entity.
Before you apply to include a medical device in the ARTG, you need to establish a relationship with the medical device manufacturer to:
- obtain documentation/information required to demonstrate that the kind of medical device complies with the regulatory requirements in Australia
- provide documentation/information relating to the regulatory, technical, clinical and safety aspects of the device that we may request at any time while you are supplying the device in Australia
- advise you of any problems, safety alerts or recalls that may arise with the use of the device.
Find out what's needed to include a medical device in the ARTG by clicking the links below.