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Tampons and menstrual cups are exempt goods and do not require an entry in the Australian Register of Therapeutic Goods (ARTG). This means that they do not require assessment by the TGA before being supplied in Australia.
To be legally supplied in Australia however, tampons and menstrual cups must comply with the relevant standards to ensure they are manufactured in a manner that will minimise recognised risks to health associated with their use.
Tampons
Tampons must comply with Therapeutic Goods (Standards for Tampons) (TGO 103) Order 2019 . TGO 103 states that the Australian Standard 'AS 2869:2008 Tampons - Menstrual' is currently the applicable standard for menstrual tampons in Australia. This standard covers a range of factors including:
- packaging
- labelling
- performance requirements
- specific absorptive capacity
- microbial content
- withdrawal cord pull strength
- water repellence.
Menstrual cups
Menstrual cups must comply with Therapeutic Goods Order (Standard for Menstrual Cups (TGO 99) Order 2018. TGO 99 covers:
- permissible raw ingredients
- design requirements
- packaging
- labelling
- information to be supplied with menstrual cups.