TGA Dental Product Reforms Need Budget Cash

The Therapeutic Goods Administration (TGA) should be provided with supplemental Australian Government funding to review the regulatory standards for dental product, according to the Australian Dental Industry Association (ADIA). The request was made in the Association's 2013 prebudget submission.

"At the urging of ADIA, the recent Senate inquiry into the regulatory standards for medical devices recommended that the TGA undertake two reviews into the regulatory standards for dental product. It's appropriate that the TGA be provided with additional funding so these reviews can be conducted in a timely manner," said Troy Williams, ADIA Chief Executive Officer.

The Senate Community Affairs Committee's inquiry recommended that the TGA consider whether custom made dental devices produced by dental laboratories are adequately regulated. To date, this review has not been undertaken.

"ADIA has been a strong advocate to secure a future for Australia's dental laboratories. That's why we are asking that the government provide the necessary funds to expedite this review," Mr Williams said.

The dental product regulatory framework was designed in the last two decades of the twentieth century and is becoming increasingly irrelevant and deficient in the twenty-first century. It is now possible to purchase dental product from overseas sources via the internet, a prospect that was not dealt with in the legislation when it was initially drafted in the 1980s and early 1990s. For this reason, the Senate Community Affairs Committee also recommended that the TGA carry out an investigation to ascertain whether importation of medical devices via the internet is adequately regulated. Again, this review has not been undertaken.

"We support the Senate committee's recommendations as many high risk medical devices such as autoclaves and tooth filling materials can be imported via the internet with no safeguards as to their fitness for use", Mr Williams said.

Through its prebudget submission, ADIA seeks to expedite adoption of the Senate Committee's recommendations. The outcome the association is seeking is a regulatory framework for dental product that is based on a risk management approach designed to ensure public health and safety, while at the same time freeing dental product suppliers from unnecessary regulatory burden.