Dental News - Australian senate support for medical device reforms welcomed

Dental Tribune International

Fri. 16. February 2018

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CANBERRA, Australia: A senate committee report recommending the passage of legislation that changes the way the Therapeutic Goods Administration (TGA) regulates medicines and medical devices has been welcomed by the Australian Dental Industry Association (ADIA). It delivers a long-standing legislative reform that ADIA has been lobbying politicians of all political persuasions to deliver on for nearly a decade.

“This bill contains important reforms that will cut the red tape associated with introducing into the Australian market new and innovative patient treatment and diagnostic options,” said ADIA CEO Troy Williams.

The bill will reportedly also make changes that support amendments to the Therapeutic Goods Act 1989 made in 2017. The reforms will allow the TGA to authorise Australian companies to undertake conformity assessments, a significant departure from past practice where only the TGA could perform such evaluations.

“This legislation, combined with the legislative changes made last year that ADIA also secured, creates a far more efficient system for dental product manufacturers to introduce new products to the Australian market. Whereas previously the TGA was the sole source of authority, the increasing use of overseas regulators and third-party Australian conformity assessment bodies will provide alternatives without compromising patient safety,” said Williams.

Williams went on to say that ADIA has been pushing for the changes because they create a regulatory framework for dental products that is based on a risk management approach designed to ensure public health and safety. He added that the reforms will simultaneously free the dental industry from any unnecessary regulatory burden.

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