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How are disinfectants regulated?

Disinfectants are regulated in a variety of ways in Australia, depending on the claims made in the instructions for use, labelling and promotional material.

Type of disinfectant How is it regulated? Comments
Sterilants and instrument grade disinfecants (all levels) - intended to be used on medical devices An accessory to a medical device - Class IIb
  • Must be included on the ARTG before they can be supplied in Australia.
  • In Europe are regulated as Class IIa. Sponsors importing these products need to ensure that the Australian regulatory requirements have been met by the manufacturer.
  • Undergo a mandatory Level 2 Application Audit.
Cleaners intended to be used on medical devices An accessory to a medical device - Class I
  • Must be included on the ARTG before they can be supplied in Australia.
Hospital grade and commercial/household grade disinfectants with specific claims* 'Other Therapeutic Goods' - registered
  • Must be registered on the ARTG before they can be supplied in Australia.
  • Must comply with TGO 54.
  • Information to be submitted for review includes instructions for use, promotional material, labels, product specifications, and efficacy, stability and quality control data.
Hospital grade disinfectants without specific claims* 'Other Therapeutic Goods' - listed
  • Must be listed on the ARTG before they can be supplied in Australia.
  • Must comply with TGO 54.
  • Information to be submitted for review includes instructions for use, promotional material and labels.
Household or commercial grade disinfectant without specific claims* 'Other Therapeutic Goods' - exempt from listing or registration
  • Exempt disinfectants are not required to be entered on the ARTG however they still must comply with certain parts of TGO 54, including the labelling requirements, and are expected to comply with performance requirements.
Antibacterial cleaning wipes
Sanitisers
Sanitary fluids/powders
(that do not make disinfectant claims)		 Exempt or excluded depending on claims
  • Claims determine if exempt from entry on the ARTG or excluded from the Therapeutic Goods Act 1989.
* 'specific claims' cover virucidal, sporicidal, tuberculocidal, fungicidal or other biocidal activity. Except where claims of activity against fungi (yeast and mould) for excluded products are concerned, these claims mean a product is registered.

If you have a problem with a disinfectant 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>.

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

More information on the regulation of disinfectants in Australia: IVDs & other therapeutic goods <http://www.tga.gov.au/othertg/index.htm>.

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