How to determine if your product should be included in the ARTG

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

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 it is:

• not a medical device
• not another sort of therapeutic good (e.g. medicine or other therapeutic good)
• an 'excluded good' or 'exempt medical device'.

What products should be entered in the ARTG?

To determine whether your product should be entered 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 medical device?

Is your product a medical device?

If your product is a medical device, it must be included in the ARTG. Your product may be 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 may also be a medical device if it is used as an accessory to any product as described above.

To decide whether your product meets the definition of a medical device, you need to consider the intended purpose of your product. Medical devices are defined by Section 41BD of the Therapeutic Goods Act 1989. 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?

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
• incontinence pads
• ear candles
• menstrual pads other than tampons and menstrual cups.

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

Is your product an exempt medical device?

Some therapeutic goods are exempt from the requirement to be entered on the ARTG (in some cases the exemption may be subject to compliance with 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

Examples of exempt medical devices include:

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

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

• Basics of therapeutic goods regulation
• Is my product a therapeutic good?
• Medical devices regulation basics
• Excluded goods orders, determinations and specifications
• Medical devices & IVDs

For more information

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

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