Cancellation from the ARTG under subsection 41GN(1) of the Act.
Grounds for regulatory action
The product is not a medical device therefore the certification made by the sponsor under paragraph 41FD(a) of the Act in the application for inclusion is incorrect.
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.