How are tampons regulated?

Tampons are therapeutic devices and need to be listed on the Australian Register of Therapeutic Goods (ARTG) <http://www.tga.gov.au/docs/html/artg.htm> 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 <http://www.tga.gov.au/docs/html/forms/iris_udir.htm>.

If you want to supply tampons in Australia, please see: What do I need to do to supply a device in Australia? <http://www.tga.gov.au/devices/supplymd.htm>.

Also see, details of the fees and charges payable <http://www.tga.gov.au/docs/html/feesach.htm>.

Please note:

• Applications for tampons are submitted by selecting the eBusiness 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 Therapeutic Goods Order 64 and 64A (AS/NZS 2869:1998) for the first batch imported is also required to be submitted.