How to Determine If Your Product Should Be Included in the ARTG

If your product is a medical device, it must be included in the Australian Register of Therapeutic Goods (ARTG) before you can legally import and/or supply it in Australia. However, do not enter your product on the ARTG if: your product is not a medical device and is not a therapeutic good (e.g. medicine or other therapeutic good) your product is...

If your product is a medical device, it must be included in the Australian Register of Therapeutic Goods (ARTG) before you can legally import and/or supply it in Australia.

However, do not enter your product on the ARTG if:

  • your product is not a medical device and is not a therapeutic good (e.g. medicine or other therapeutic good)
  • your product is an 'excluded good' or 'exempt good'.

This page is intended to help you to decide if your products are required to be included in the ARTG. It also outlines what to do if you have included a product incorrectly.

If your product is not a medical device or therapeutic good or is an exempted or excluded good, do not enter it into the ARTG

What products should be included in the ARTG?

To determine whether your product should be included in the ARTG, you should consider the following questions:

  • Is your product a medical device?

  • Is your product another type of therapeutic good (e.g. other therapeutic good or medicine)?
  • Is your product an excluded good?
  • Is your product an exempt good?

Is your product a medical device?

If your product is a medical device, it must be included in the ARTG. Your product is a medical device if it is intended by the manufacturer to be used on humans for any of the following:

  • diagnosis, prevention, monitoring, treatment or alleviation of disease

  • diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability
  • investigation, replacement or modification of the anatomy or of a physiological process
  • control of conception.

Your product is also a medical device if it is used as an accessory to any product as described above.

In order for you to decide whether your product meets the definition of a medical device, you need to consider the intended purpose of your product. You can find out the intended purpose of your product by looking at the information that the manufacturer provided with the device.

Is your product a therapeutic good?

If your product is a therapeutic good, it must be entered in the ARTG. Even if your product is not a medical device, it may still be another type of therapeutic good (e.g. other therapeutic good or medicine).

To understand what type of product you have, you could use the decision tool: Is my product a therapeutic good?

Products that are not therapeutic goods should not be entered on the ARTG.

Is your product an excluded good?

Some low-risk products are excluded from the TGA's regulatory framework and should not be included in the ARTG. Examples of excluded goods include:

  • adhesive removers relating to colostomy and ileostomy

  • dental bleaches and dental whiteners
  • ear candles
  • menstrual pads other than tampons and menstrual cups.

For the complete list of excluded goods, refer to:

It is your responsibility to check that your product is correctly included in the ARTG

If you are a sponsor of a medical device, it is your responsibility to check that your medical device is correctly included in the ARTG. If you identify that your product is incorrectly included, you should request cancellation of the ARTG entry.

You can request cancellation of your ARTG entry by logging into your sponsor TBS portal or by completing a paper based form available on the TGA website.

The TGA will contact sponsors with incorrect ARTG entries

The TGA reviews ARTG entries for products that we expect may not be therapeutic goods. If we identify incorrect ARTG entries, we write to sponsors seeking clarification on why they have included their products in the ARTG. We can assist you with determining whether your product is correctly included in the ARTG and, if needed, we can assist you with the cancellation of your ARTG entry.

Useful links

For more information

If you have questions and want to discuss your product, please contact medical devices info line:

Source: www.tga.gov.au