ADIA criticises TGA’s revised regulation of medical devices

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The Australian Dental Industry Association [ADIA] has criticised the Therapeutic Goods Administration’s [TGA] reduced regulation of medical devices, leading to a decreased number of products available in the Australian market. “Businesses across the dental industry are withdrawing products from the market as a result of the TGA’s new fee regime that was introduced this financial year,” said Troy Williams, the chief executive officer of ADIA of the new fee regime introduced this financial year.

The adverse outcome of the new structure, the ADIA outlines, is a result of charges businesses pay to place product on the Australian Register of Therapeutic Goods [ARTG], maintained by the TGA, and is a list of medicines and medical devices that can be lawfully supplied in the country. “The result of the TGA’s changes is reduced competition in the sector with dental professionals having a diminished range of products to choose from, which means reduced patient care options,” said Williams.

“Faced with paying higher TGA fees, businesses across the dental industry are taking products off the ARTG with the result that the products cannot be lawfully supplied by these businesses in Australia. This is not the preferred course of action by these businesses, but the TGA’s higher fees now means that it is not commercially viable to keep supplying these products to dentists.

The ADIA has begun a dialogue with the Assistant Minister for Health seeking an independent review of the TGA’s new charges, hoping to use the review as the basis for a more equitable TGA charges framework in the next financial year. “The TGA has stated that its new fee structure was intended to reduce business compliance costs, yet the experience of businesses across the dental industry is very different,” said Williams.

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