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Regulation of cleaners and disinfectants: Information for sponsors and manufacturers
In light of the current COVID-19 situation, there is significant interest from potential sponsors and manufacturers on how disinfectants are regulated and how to supply them.
What disinfectants claim to do will determine how they are regulated by the Therapeutic Goods Administration (TGA) under the Therapeutic Goods Act 1989 (the Act). Claims may be made on the labels, instructions for use or on promotional material.
Due to COVID-19, all disinfectant applications in relation to claims against COVID-19 are being expedited as a matter of priority.
Medical device cleaners and disinfectants
Cleaners intended to be used on medical devices that do not claim to be a device disinfectant or sterilant are regulated as Class I medical devices.
Liquids, sprays, wipes and aerosols intended to be used on medical devices that make disinfectant or sterilant claims are regulated as Class IIb medical devices.
Medical device cleaners and disinfectants must be included on the Australia Register of Therapeutic Goods (ARTG) prior to supply in Australia.
Hard surface disinfectants
Hard surface disinfectants:
- are not intended for use on medical devices
- may be intended for use in hospitals or similar settings, or in non-healthcare settings such as the home, school, workplaces or other premises.
Hard surface disinfectants are labelled as hospital, household or commercial grade disinfectants, depending on where they are intended to be used or the level of performance testing the product has passed. For example, many products labelled as household disinfectants contain the same active ingredients as products labelled as hospital grade disinfectants.
Claims that a product kills, or is active against, viruses, spores, tuberculosis, mycobacteria or fungi are "specific claims". Disinfectants that make these claims require listing on the ARTG prior to supply in Australia.
Disinfectants that do not make "specific claims" do not require inclusion on the ARTG prior to supply, but must still meet all regulatory requirements for exempt disinfectants.
General cleaners and sanitisers that do not make disinfectant claims (except those for use on medical devices) are not regulated by the TGA.
Claims and advertising about COVID-19
When making new label claims against microorganisms, including COVID-19, the disinfectant must be compliant with the Therapeutic Goods (Standard for Disinfectants and Sanitary Products) (TGO 104) Order 2019 and the TGA instructions for disinfectant testing.
Follow the TGA's advice on the use of surrogate viruses for COVID-19 for efficacy testing.
- Overview of how disinfectants are regulated within Australia.
- Guidance on the regulation of listed disinfectants, including how to list on the ARTG.
- Guidance on exempt disinfectants
- Advertising in connection with COVID-19
- Information about how to include medical devices (including IVD medical devices) on the ARTG
- Disinfectants: Information for new sponsors
- Disinfectants: FAQ for new sponsors
If you have any questions about applications for disinfectants, contact the Medical Device Information Service at email@example.com or 1800 141 144.