Senate Inquiry — Regulatory Standards For Medical Devices

The Australian Dental Industry Association (ADIA) has supported the work of the Senate inquiry reviewing the regulatory standards for the approval of medical devices.  The inquiry was established by the Senate's Community Affairs committee and the final report was tabled in the Senate on 22 November 2011.

The Senate Committee inquiry follows widespread concerns with artificial hip implants and following media reports related to this type of medical device there were calls for a senate inquiry.  After consulting with its members, ADIA successfully worked with a number of Senators with the aim of having the scope of the committee's inquiry widened to include all medical devices.

Amongst the issues that were considered is the role of the Therapeutic Goods Administration (TGA) in regulating the quality of devices available in Australia; the processes in place to ensure that approved products continue to meet Australian standards; the safety standards and approval processes for devices that are remanufactured for multiple use; and the processes in place to notify the relevant authorities and the general public of high revision rates or possible faulty devices. A copy of ADIA's submission and the Senate Committee's final report can be downloaded from the links below:

Key Documents - Productivity commission inquiry:
  ADIA Submission - Inquiry into regulatory standards for medical devices [PDF]
  Senate Committee Report - Inquiry into regulatory standards for medical devices [PDF]

In its submission to the Senate Inquiry, ADIA raised a number of issues relating to the regulations governing the supply of medical devices, primarily dealing with the importation of dental product via the internet.  During subsequent meetings with Senators in Parliament House, Canberra, ADIA was able to raise the issue of custom made dental appliances. 

In a significant victory, ADIA was able to gain acceptance of this point and the committee’s report states that the
unregulated importation of dental devices via the internet may indicate a much broader problem of inadequate regulation of other medical devices purchased through the internet. The Senate committee is of the view that this requires further investigation and assessment by the TGA.  There were two key recommendations of interest to the dental industry:

• The committee recommends that the TGA 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; and
• The committee recommends that the TGA carry out an investigation to ascertain whether importation of medical devices via the internet is adequately regulated.  

In commenting to the media on the committee's final report the ADIA Chief Executive Officer, Troy Williams, said that ADIA was pleased the Senate Committee has noted the lack of effective regulation associated with the importation of medical devices.  ADIA is seeking a regulatory framework for the supply of dental product 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.

 The ADIA-DRC Dental Regulation Committee is monitor progress of the inquiry and continues to lobby for a regulatory environment that supports suppliers of quality dental product.

To keep up to date with this issue follow ADIA on Twitter @AusDental or contact the ADIA national office via email at government.affairs@adia.org.au or telephone 1300 943 094 (internationally on +61 2 9319 5631).