Australasian Dentist Issue 89

AustrAlAsiAn Dentist 37 proDuCt proFIle as a class IIb medical device or as per the cleaner range one that has been regulated by the TGA as a device. These are the only materials that you can obtain an ARTG number for and should request prior to being used within your surgery or laboratory. These products have been evaluated by the TGA within the regulatory framework to be effective and in accordance with the manufacturer’s recommendations and fit for purpose. The volume of the product to use should be explained within the label instructions on the product and within the Instructions for use (IFU) and any advertising materials. You would also have seen many advertisements sent to you that particular products to be used in your practice are effective against Sars-2 Covid -19. Why can manufacturers make this claim? Disinfectants for use against COVID-19 in the ARTG for legal supply in Australia The TGA has recently received a number of enquiries seeking to know which disinfectants have been entered into the ARTG for use against COVID-19. Claims that a disinfectant has an effect against any virus must be expressly permitted by the TGA before being used in consumer advertising (including on the label). In response to the COVID-19 pandemic, the TGA has permitted SARS-CoV-2 and COVID-19 virus claims. The see the list of disinfectant products that have been entered into the ARTG with specific claims against SARS-Cov-2 (COVID 19) or COVID-19 on the product label refer to the following link: https://www.tga . gov.au/disinfectants-use-against-covid-19-artg- legal-supply-australia Note this list is constantly changing and being updated as many manufacturers are now complying with TGA requirements. Remember that a listed device is a hospital grade disinfectant and is not to be used on your medical devices. Only Included devices that have an ARTG number can be used as per regulatory requirements on your medical devices, so when you review this list, look for Included devices. Take not of the products that say: Therapeutic type: Medical Device included Class IIb www.ids-cologne.de 22. – 25.09.2021 4 DAYS IN COLOGNE 39 TH INTERNATIONAL DENTAL SHOW PROVIDING DIRECTION IN UNCERTAIN TIMES IDS inclusive connect #B-SAFE 4business Robert Laing Messe Reps. Pty. Ltd. Tel. +61 427353536 robert@messereps.com IDS_2021_Anzeige_Australasian_Dentist_180x128mm_Intl_GB_AU.indd 1 15.06.21 11:21 If a manufacturer wishes to comply with the TGA regulations to claim Covid -19 effectiveness then Medical device inclusion process – step-by-step guide can be found at https://www.tga.gov.au/applying-tga- assessment-covid-19-test-inclusion-artg This article has been prepared by Dr Roy J Hardman who as an external agent to the TGA assisting organizations comply with the TGA requirements has had extensive experience guiding organizations through the regulatory requirements to achieve inclusion on the Australian Register of Therapeutic Goods. For further information and guidance contact Dr Roy J Hardman Right Time Business E: roy@righttimebusiness.com.au Ph: 0419 100 978 PO Box 1003 Hartwell Victoria 3124.