Confirm your product needs to be in the ARTG as a medical device

This page will help you determine if your product is a therapeutic good and if it is a medical device that needs to be included in the ARTG. 

Check if your product is a therapeutic good

Check the following to see if your product is a therapeutic good. Therapeutic goods include medical devices, medicines, biologicals and other therapeutic goods:

• What are therapeutic goods?
• Overview of supplying therapeutic goods in Australia.

Use the is my product a therapeutic good? tool to find out if your product is a therapeutic good.

Check if your product is a medical device

You can work this out by looking at the manufacturer’s instructions for use, advertising materials, technical documentation, and product labels. 

Make sure the manufacturer’s intended purpose matches the legal definition of a medical device—and, if relevant, the IVD medical device definition. Medical devices are defined in section 41BD of the Therapeutic Goods Act 1989 and clarified by the 2020 Specified Articles Instrument.

If you change the intended purpose, you become the manufacturer under the law and must comply with all manufacturer obligations under the relevant legislation.

Check if your product is 'not a medical device'

Check if your product is listed as not a medical device in the Therapeutic Goods (Articles that are not Medical Devices) Declaration 2023.

Check if your product is 'excluded' from regulation

If your product is excluded, the TGA does not regulate it and you don’t need to include it on the ARTG before exporting, importing or supplying it in Australia.

Check the Therapeutic Goods (Excluded Goods) Determination 2018 to see if your product is excluded from regulation.

Check if your IVD self-test is prohibited in Australia

Review the Therapeutic Goods (Medical Devices - Excluded Purposes) Specification 2020 to check if your IVD medical device is prohibited for self-testing in Australia.

Check if your product is 'exempt' from inclusion

Medical devices exempt from inclusion in the ARTG are products:

• supplied for clinical trials in Australia,
• prescribed by authorised prescribers,
• supplied under the Special Access Scheme,
• imported for personal use under the Personal Importation Scheme, or
• that are custom-made medical devices.