Disinfectants and sterilants are regulated in different ways by the Therapeutic Goods Administration (TGA) depending on the intended purpose and labelling claims.
-
GuidanceGuidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.
-
GuidanceGuidance for new sponsors on how to supply, import, and export disinfectant products.
-
-
PageInformation for new sponsors about the supply of disinfectant products.
-
PageInformation on the different ways we regulate disinfectants depending on the intended use and label claims.
-
GuidanceGuidance on how exempt disinfectants are defined and meeting the regulatory requirements for their manufacture, supply and advertising.
-
GuidanceInformation to help sponsors and manufacturers decide if antiviral‑claim products need ARTG entry to be imported or supplied in Australia.
-
GuidanceGuidance on testing of disinfectants and sterilants so they meet quality, safety and efficacy requirements specified in Therapeutic Goods Order 104.
-
PageDevice Requirements version 4 (DR4) provides guidance on transition arrangements for 'retained registered disinfectants' regulated under the pre- 4 October 2002 regulatory framework for medical devices.