Summary of disinfectant regulation

On 11 April 2012, the Therapeutic Goods Administration (TGA) released a summary of disinfectant regulations. 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 disinfectants (all levels) – intended to be used on medical devices Class IIb ‘Medical Device’ – included Must be ‘included’ in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in Australia. In Europe some of these products are regulated as Class IIa medical devices and others as Class IIb medical devices. Sponsors who import these products need to ensure that the Australian regulatory requirements for Class IIb medical devices have been met by the manufacturer. Applications for these types of devices must be selected to undergo an audit prior to inclusion in the ARTG. Cleaners intended to be used on medical devices Class I ‘Medical Device’ – included Must be ‘included’ in the ARTG before they can be supplied in Australia. Hospital grade and commercial/household grade disinfectants with specific claims* ‘Other Therapeutic Goods’ – registered Currently must be registered on the ARTG before they can be supplied in Australia. Must comply with Therapeutic Goods Order Number 54 (TGO 54). A pre-market review of these goods is conducted. Information to be submitted for review includes; instructions for use, promotional material, labels, product specifications, and microbial 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 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 in the ARTG or excluded from the Therapeutic Goods Act 1989. * The term ‘specific claims’ covers 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. A ‘non-specific claim’, is a claim which includes general antibacterial action or activity against vegetative bacteria (excluding mycobacteria) covered by the battery of test organisms included in the specified test, or bacteria of the same genus. Claims for bacteria other than these are allowable, but the specific organism against which activity is claimed must be included as an extra organism in the test battery e.g. E. coli O157, Salmonella spp, Streptococcus spp, etc.

Therapeutic Goods Administration, 11 April 2012 ;http://www.tga.gov.au/ ;