Disinfectants and sterilants
Information and guidance on disinfectant and sterilant regulation and manufacturing requirements in Australia.
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Disinfectants and sterilants are regulated in different ways by the Therapeutic Goods Administration (TGA) depending on the intended purpose and labelling claims.
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GuidanceGuidance on how sterilants and disinfectants are regulated in Australia. List of relevant legislation.
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GuidanceGuidance for new sponsors on how to supply, import, and export disinfectant products.
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PageExplore FAQs for new sponsors about the supply of disinfectant products.
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PageInformation on the different ways we regulate disinfectants depending on the intended use and label claims.
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GuidanceGuidance on how exempt disinfectants are defined and meeting the regulatory requirements for their manufacture, supply and advertising.
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Reference materialHow we define and regulate listed disinfectants, including guidance on how to submit a product application and the supporting data and other information required.
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GuidanceInformation to assist sponsors and manufacturers of products making antiviral claims determine if their product require an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied in Australia.
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GuidanceGuidance on testing of disinfectants and sterilants so they meet quality, safety and efficacy requirements specified in Therapeutic Goods Order 104.
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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.