ADIA moves to support labs

The Australian Dental Industry Association (ADIA) is spearheading an industry review of the regulatory standards for crowns, bridges and other custom-made dental appliances. This initiative stems from difficulties that the Therapeutic Goods Administration (TGA) has in verifying the quality of both the raw materials in these products and adherence to statutory manufacturing quality standards.

In November 2011, the Senate Community Affairs References Committee, as part of its inquiry into the regulatory standards for medical devices, reviewed the regulations surrounding the importation of custom-made dental devices. As a result of the advocacy efforts of ADIA to secure a future for Australia's dental laboratories, in its report tabled in November 2011 the senate committee said:

"The committee recommends that the Therapeutic Goods Administration consider whether custom made dental devices are adequately regulated; and whether the approach used in the United Kingdom of requiring a statement of manufacture to be provided to patients and retained by the dental practitioner, has merit."

Upon receiving the Australian Government's response in August 2012, ADIA prepared a submission that formally requested that the TGA move to implement the Australian senate committee's recommendation. This submission is now with the TGA for consideration.

To further investigate the impacts surrounding this reform, ADIA has formed an industry task group to consider this matter in detail. The task group will review the regulatory standards for the approval of custom-made dental devices in Australia, with particular attention on securing compliance with the essential principles set out in the Therapeutic Goods (Medical Devices) Regulations 2002 irrespective of the product's country of manufacture. The task group will consider in detail:

• The role of the TGA in regulating the quality of custom-made dental appliances available in Australia;
• The processes in place to ensure that approved products continue to meet the essential principles; and
• The effectiveness of processes in place to notify the relevant authorities about possible faulty devices.

In considering these matters, the task group will identify all possible regulatory and policy responses and tender advice to the ADIA Board on whether or not each option should be progressed and if it is dismissed, the reasons for doing so. The membership is open to representatives of the following groups:

• ADIA Member businesses that are dental laboratories;
• ADIA Member businesses that supply product to dental laboratories; and
• A representative of the Oral Health Professionals Association (OHPA).

The task group is to report to the ADIA Board in mid-2013 and should it recommend that further regulatory reform is required, ADIA is well-positioned to secure reform as it is the dental industry's peak representative body on a number of TGA committees with responsibility for regulatory reform. Beyond liaising directly with the TGA, ADIA continues its advocacy at a parliamentary level.

In progressing any reform to secure a future for Australia's dental laboratories, ADIA's priority will be to ensure that the revised regulatory standards for custom-made dental appliances are based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden.

Troy Williams - ADIA Chief Executive Officer

For more information and a copy of ADIA's most recent submission to the TGA please visit www.adia.org.au/labs