Continuous glucose monitors (CGMs) are now easy to buy online, and prices vary a lot. Some sensors sold to Australians through marketplaces and overseas websites have never been assessed by the Therapeutic Goods Administration (TGA). Before you buy, it's worth spending two minutes checking.
What "TGA approved" actually means
A CGM is a medical device. To be legally supplied in Australia it generally has to be included on the Australian Register of Therapeutic Goods (ARTG), the TGA's public database of approved therapeutic goods. Each entry has an ARTG number and names the Australian sponsor who is responsible for the product here.
The TGA notes that supplying a medical device that isn't on the ARTG is an offence unless an exemption applies, and that devices bought online from overseas may not meet Australian safety, quality and performance requirements, may come without a warranty or instructions, and may not be covered by recalls.
How to check a CGM in three steps
- Ask for the ARTG number. A legitimate Australian seller should be able to give it to you, and many print it on the product page.
- Search the register. Go to the TGA's ARTG search at tga.gov.au/resources/artg and enter the ARTG number. You can also search by product or manufacturer name.
- Check the entry matches. Make sure the entry describes the same type of device (a continuous glucose monitoring system) and the same manufacturer as the product you're buying. The name on the entry can be a technical description rather than the retail brand name, so check the manufacturer and sponsor too.
If you can't find an entry, or the seller can't give you a number, treat that as a warning sign and ask your doctor, pharmacist or diabetes educator before buying.
Other things worth checking
- Who supports it in Australia. If a sensor fails early or the app won't pair, you want a local supplier who will answer.
- Whether the app works here. Some CGM apps are only published in certain countries' app stores.
- Units. Australian readings are in mmol/L. Devices set up for overseas markets may default to mg/dL.
- Claims that sound too good. The TGA warns consumers to be wary of devices promising miracle results or claiming to diagnose many conditions.
The iCan i6 on the ARTG
The iCan i6 CGM we supply is included on the ARTG under ARTG 515190. You can look it up yourself using the steps above. See the iCan i6 CGM.
Report a concern
If you think a device is being sold in Australia without being on the ARTG, or you've had a problem with a medical device, you can report it to the TGA through its website.
This article is general information, not medical advice. Glucose targets and monitoring should be set with your doctor or credentialled diabetes educator. Always read the label and follow the directions for use.