Guidance on the regulation of tampons in Australia
Version 1.0, August 2017
The purpose of this guidance is to help sponsors understand how the TGA interprets regulations, and thus indicate how a sponsor can comply.
This is a guide only, and sponsors are encouraged to familiarise themselves with the legislative and regulatory requirements in Australia. If necessary, seek professional advice as it is the responsibility of each sponsor to understand and comply with these requirements.
This document will evolve over time and updates and clarifications will be included as required. Feedback on the guidance is always welcome.
AS 2869-2003. Copied by the Therapeutic Goods Administration [TGA] with the permission of Standards Australia under Licence 1704-c006-2.
Tampons are therapeutic products which are regulated as 'Other Therapeutic Goods'. Before they can be supplied in Australia, they must be listed on the Australian Register of Therapeutic Goods (ARTG).
Tampons supplied in Australia must comply with Therapeutic Goods Order No.82 - Standard for Tampons - Menstrual. This order states that the Australian Standard "AS 2869:2008 Tampons - Menstrual" is currently the applicable standard for menstrual tampons in Australia.
AS 2869:2008 aims to ensure that tampons are manufactured in a manner that will minimise recognised risks to health associated with the use of these products. The standard covers a range of factors including, but not limited to:
- Performance requirements
- Specific absorptive capacity
- Microbial content
- Withdrawal cord pull strength
- Water repellence
You can obtain a copy of AS 2869:2008 Tampons - Menstrual from SAI Global.
If you have a problem with a tampon, please tell us about it using the Report a medical device adverse event (medical device user) form.
Tampons must meet AS 2869:2008 Tampons - Menstrual.
It is an offence to import and/or supply the therapeutic goods in Australia that do not conform with a standard applicable to the goods (refer sections 14 and 14A of the Therapeutic Goods Act 1989).
Related guidance and legislation
Tampons must also adhere to the requirements as set out in the: