TGA and Menstrual Cups in Australia
The Therapeutic Goods Administration – the TGA – is the governing body for Australia that has a similar role to the FDA in the USA. Menstrual cups are regulated by the TGA, and must be registered before they can legally be sold in Australia (the same way cups must be registered with the FDA to be legally sold in or to the USA)
“Menstrual cups are therapeutic devices and need to be included on the Australian Register of Therapeutic Goods (ARTG) before being sold in Australia. The TGA regulates menstrual cups as ‘Other Therapeutic Goods’.”
Cups that are purchased from overseas sources for your own personal use, do not need to be registered with the TGA, as it is legal to import an unregistered item (that is not prohibited) for your own use. However it is not legal to sell a menstrual cup in Australia unless it is registered with the TGA.
As of 13th Sept 2016 – the following are the only menstrual cups that appear under a search for “menstrual cups” on the ARTG:
Does this mean that Australians should only buy one of these cups?
No. Other brands of menstrual cup are available for you to use, when purchased from outside of Australia. Looking for a cup brand that is FDA registered will give you the same assurance of quality/safety as if they were TGA registered. However many good quality cups are neither TGA or FDA registered. It is just that only cups that are on the ARTG are legally allowed to be sold within Australia.
As the TGA registration fees are quite costly, some consumers feel it is good to support those cup brands who have done the right thing by being registered and providing choices for Australian women to purchase cups within Australia, even if the cup prices are higher than you could purchase overseas for.
What about the other cups people are selling in Australia?
There are a few cups being sold in Australia that do not appear to be TGA registered, as they do not appear in the ARTG search for “menstrual cups” – many of these also appear to be Rebrandings of cups that are available to purchase in bulk for as little as 50c each.
So while I do not make recommendations about purchasing or not purchasing from any particular seller – as this is a decision you must make for yourself – it would seem to me that if you are going to purchase a Rebranded menstrual cup that is not TGA or FDA registered and therefore unknown in quality (See my article on the quality concerns for cheap cups) – it is likely to be better value to buy a cup from a cheaper overseas source than to buy what appears to be the same cup that is being illegally sold in Australia at a much higher markup.
Or pay a higher price to buy (and support) one of the cup brands who have done the right thing and registered with the TGA.
If you feel that it is a concern for people to be selling menstrual cups in Australia that are not registered with the TGA, then the TGA website has a contact page you can use to notify the TGA of this issue.
Examples of brands that do not appear to be TGA registered, and appear to be Rebrandings of cheaper cups:
AliExpress and ebay appear to be selling the same cups from around $1.50 AUD for one style and $8.90 AUD the other (including postage)
The iCare and Anytime are selling at less than $7 AUD (inc. postage) direct from the manufacturer on AliExpress
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