Therapeutic Goods Administration - Medical device reforms reference committee

The Therapeutic Goods Administration (TGA) has formed a reference group to provide high-level advice on the proposed reforms to the medical device regulatory framework. The Reference Group is Chaired by Ms Jenny Hefford, TGA Chief Regulatory Officer, and will provide a consultation mechanism between key stakeholders, including the Australian Dental Industry Association (ADIA) and the TGA on issues relating to the medical devices reforms.

Terms of reference:
	To provide the TGA with advice in proposed changes, including implementation considerations and risks and benefits associated with the proposed changes;
	To provide the TGA with advice in documentation that may be required to support new legislative instruments; and
	To provide the TGA with advice in matters related to the medical devices reforms.

An early issue is around scope is the relationship between this Reference Group and the recent recommendations made by the Senate Inquiry into the Regulatory Standards for the Approval of Medical Devices. At this time, a formal Government response to the Senate Inquiry report has not been made and is therefore not appropriate for the Reference Group to pre-empt any formal Government response. However, as there are significant areas of overlap between the Senate Inquiry recommendations and the approved medical device reforms proposals announced in September 2011, the TGA will be seeking input from Reference Group members about these issues as per the Terms of Reference above. The composition of the reference group is as follows:

The Reference Group's role will be to provide feedback to the TGA on proposed regulatory amendments and implementation approaches regarding the medical device reforms, but it is important to note that the Reference Group will not have decision making responsibilities. There are other areas covered by the Senate Inquiry recommendations which are also already being progressed by the TGA, such as the issue of improving regulation of custom-made medical devices, on which the TGA has advised it is anticipated that Reference Group members input will be sought.

As issues arise from the Reference Group they will be forwarded to ADIA-DRC Dental Regulation Committee members for review and comment with feedback received forwarded back to the TGA for consideration.  In tendering advice to the TGA, ADIA's priority will be to allow the Australian Government to achive its desired policy objectives while at the same time freeing the dental industry from an unnecessary regulatory burden.

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