Proposals to levy a new fee on suppliers of medical devices have been formally rejected by the Australian Dental Industry Association.
The new fee has been proposed by the Therapeutic Goods Administration (TGA) for businesses applying to place new low-risk medical devices on the Australian Register of Therapeutic Goods (ARTG), the list of therapeutic products that can be lawfully supplied in Australia.
“Australia’s dental industry is primarily composed of small businesses with less than 10 employees,” ADIA CEO Troy Williams said.
“Like all small businesses they are already under pressure and the TGA’s new fee just makes things harder.”
Whereas business previously could place low-risk medical devices on the ARTG without paying an application fee, the TGA has proposed that from 1 July 2018 there will be a cost of $530 for each new entry. It is estimated that for these small businesses the cost will be between $4,240 and $13,250 per year.
The ADIA membership supplies around 95 per cent of the medical devices used in dental practices nation-wide and the advice from these suppliers is the new fee will make it commercially unsustainable to introduce new specialised products that are likely to be sold in low volumes.
“SMEs across the dental industry have made it clear this new $530 fee creates a new barrier to the entry of new and innovative products into the Australian marketplace,” Williams said.
“The losers will be dental professionals and their patients that won’t be able to access these new advances.”
Based on a media release sourced from the ADIA website.
