Determining if your medical device should be in the Australian Register of Therapeutic Goods (ARTG)

Your product might be a medical device if it’s used for:

• 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 may also be a medical device if it is an accessory to any product as described above.

The definition of a medical devices is in Section 41BD of the Therapeutic Goods Act 1989.

Even if your product is not a medical device, it may still be another type of therapeutic good.

Use the ‘Is my product a therapeutic good?’ tool to work this out.

Exempt

Does not need to be on the ARTG but may need to comply with certain conditions.

Excluded

Does not need to be on the ARTG and has no conditions that need to be met.

Excluded

Our regulatory framework excludes some products. In this case, you don’t need to include it on the ARTG.

Examples include:

• adhesive removers relating to colostomy and ileostomy
• incontinence pads
• ear candles
• menstrual pads other than tampons and menstrual cups.

For more information, refer to excluded goods orders, determinations and specifications.

Exempt

Some therapeutic goods are exempt from needing to be on the ARTG.

These include:

• custom-made medical devices, or
• Class 1, 2, 3 in-house IVDs (subject to certain conditions).

For the complete list of exempt medical devices, refer to the:

• Therapeutic Goods (Medical Devices) Regulations 2002 - Schedule 4 (Part 1 and 2) - Exempt devices

As a medical device sponsor you are responsible for checking your device is on the ARTG. If your product is incorrectly included, you should request cancellation of the ARTG entry.

To cancel an entry, you can do this by either:

• using the TBS portal or
• completing a paper-based form.

We review ARTG entries for products that we expect may not be therapeutic goods. Our team will get in touch with sponsors if we notice an incorrect ARTG entry.

If you have any questions, contact us:

• Email devices@tga.gov.au
• Phone 1800 141 144

• Medical device regulation basics