How tampons are regulated in Australia

16 March 2009

Tampons are therapeutic devices and need to be listed on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. The TGA regulates tampons as 'Other Therapeutic Goods'.

If you have a problem with a tampon, please tell us about it: Medical device adverse event reporting by medical device users.

If you want to supply tampons in Australia, please see: What do I need to do to supply a device in Australia?.

Also see, details of the fees and charges payable.

Please note:

  • Applications for tampons are submitted through TGA eBusiness Services by selecting the option: Other goods - not medical devices - Listed.
  • Applications are subject to an audit process which is carried out once the TGA receives the application and prior to listing on the ARTG.
  • Information to be submitted for review includes product information, instructions for use and promotional material, labels (draft or sample) supply and primary pack.
  • A test certificate demonstrating compliance with TGO 82 (AS/NZS 2869:2008 Tampons - Menstrual) for the first batch imported is also required to be submitted.
  • From 5 March 2011, all tampons must comply with TGO 82.