- Australian Government Announces Reforms To Support Dental Laboratories

19 September 2012 - To read the whole e-update, click here

Last year the Senate Community Affairs committee conducted an inquiry into the regulatory standards for custom-made medical devices.  As a result of representations made by the Australian Dental Industry Association (ADIA), the committee recommended that the Therapeutic Goods Administration (TGA) consider whether custom made dental devices are adequately regulated; and whether an approach requiring a statement of manufacture to be provided to patients, and retained by the dental practitioner, has merit.
Since the Senate committee’s report was released, ADIA has held a number of meetings with parliamentarians to secure reform in this area.  Indeed, the most recent of these meetings was held at Parliament House, Canberra, earlier this month.

Late last week, the Australian Government responded to the Senate committee's recommendations.  The Australian Government has noted that custom made dental devices are not required to be included on the Australian Register of Therapeutic Goods (ARTG). However, the Australian Government has reinforced that there are a number of requirements that must be met.
The therapeutic goods legislation requires that the importers of custom made dental devices hold certain details about the device including information identifying the manufacturer and any special characteristics of the device.  The Australian Government will consult with the Dental Board of Australia on this recommendation, as the governing body with the authority to regulate the dental profession as to how ensure that these requirements will be met.


Troy Williams
ADIA Chief Executive Officer
e: ceo@adia.org.au    twitter: @AusDental




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