Medical device inclusion process
Steps to include a medical device (including IVD medical devices) in the Australian Register of Therapeutic Goods (ARTG).
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 in order 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.
Please click on the links below, to find out what is needed to include a medical device in the ARTG.
Check your product needs inclusion
- PageCheck if your product is a medical device and if it needs to be included in the Australian Register of Therapeutic Goods (ARTG).
Things to consider before you apply
Accessing TGA Business Services
You will need to have a Client ID and access to the TGA Business Services (TBS) website in order to submit your medical device application. Follow the link below for information about setting up and maintaining your TGA account.