collaborating with the Low Risk Devices Working Group of industry stakeholders to develop guiding principles for determining which products are very low risk and therefore should be excluded from regulation, including Products used for and by people with disabilities.
review of existing Class I medical devices in the ARTG to ensure they meet the requirements for inclusion, with product types identified as not meeting these requirements to be removed from the ARTG.
As part of this review the TGA has developed a self-assessment tool to determine if a product is a medical device. This tool is also available to potential applicants at Is my product a medical device?.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.