You are here Home How we regulate Supply a therapeutic good Supply a medical device Medical devices reforms Medical devices reforms: low-risk products Project status: in progress Appropriate regulation of low risk devices to improve consumer safety, reduce regulatory burden and improve knowledge of regulations. Last updated 22 August 2024 Listen Print Share LinkedIn (Twitter) Facebook Email Loading... Project overviewIn response to the 2015 Expert Review of Medicines and Medical Devices Regulation, the TGA reformed the regulation of a number of low-risk productsReform to the regulation of low-risk products is occurring two streams:Class 1 medical devicesOther therapeutic goods and excluded goodsFurther reforms to low-risk devices are under consideration.ConsultationsConsultationStatusOptions for the future regulation of 'low-risk' productsThe future regulation of low-risk productsConsultations closed 12 May 2017Targeted consultation on TGO 103 on tampons (Explanatory Statement)Consultation concluded March 2019Review of Therapeutic Goods Order 54 - Standards for Disinfectants; and associated guidanceConsultation closed on 12 February 2019Consultation: Products used for and by people with disabilitiesConsultation closed 25 October 2019More informationConsultations and reviews. Topics In Vitro Diagnostic medical devices (IVDs) Main navigation