Medical device inclusion process

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.