The public consultation indicated the importance of the TGA’s role as the regulator of
medical devices, affirming that in the majority of cases medical devices should not be
excluded even where the risks associated with them are considered to be very low risk.
Products proposed for exclusion are therefore limited to the following:
• Products that are already excluded or that do not meet the definition of a medical device
but where clarification of the product’s regulatory status would be of benefit.
• Accessories to medical devices for which regulation under the therapeutic goods
regulatory framework is not commensurate with the risk that such products would pose to
a user.
• Products that meet the definition of a medical device where the primary purpose is
cosmetic.
• Anatomical models that are manufactured using a cast taken from a direct physical
impression from a patient’s anatomy…
