Senate Set To Pass Medical Device Reforms
3rd Feb 18
A Senate committee has recommended passage of legislation that will cut the the red tape associated with introducing new dental products to the Australian market. It's a legislative reform that the Australian Dental Industry Association (ADIA) has long argued for and represents a significant win for the Association's membership.
Key Issues For The Dental Industry —
The Senate Community Affairs Legislation Committee handed down its report (dated 2 February 2018) on the Therapeutic Goods Amendment (2017 Measures No. 1) Bill 2017 which provides the legislative amendments that will allow the Therapeutic Goods Administration (TGA) to utilise the work of comparable overseas regulators in the course of making assessments of dental products and other medical devices.
ADIA provided advice to the Senate committee that the proposed reforms will cut the red tape associated with introducing into the Australian market new and innovative patient treatment and diagnostic options. A copy of the proposed legislation, ADIA's submission to the Senate inquiry reviewing the Bill and the committees report can be downloaded from the links below:
ADIA has been a long-standing proponent for this reform that will shorten the timeframe associated with gaining domestic market approval from the TGA for not only dental products, but most types of medical devices. In a practical sense, this is what a cut to red-tape looks like.
This Bill also makes changes that supports amendments to the Therapeutic Goods Act 1989 (Cth) made in 2017. These reforms allows the TGA to authorise Australian companies to undertake conformity assessments, a significant departure from past practice where only the TGA could do this.
This legislation, combined with the legislative changes made last year that ADIA also secured, creates a far more efficient system for dental product manufacturers to introduce new product to the Australian market. Whereas previously the TGA was the sole source of authority, the increasing use of overseas regulators and third-party Australian conformity assessment bodies will provide alternatives without compromising patient safety.
ADIA is confident that the legislation will pass the Senate soon and, having been passed by the House of Representatives in December 2017, will soon become law. It delivers a long-standing legislative reform priority that ADIA, over nearly a decade, has been lobbying politicians of all political persuasions to deliver.
ADIA has been pushing for these changes as it creates a regulatory framework for dental products that is 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.
Member Engagement —
The association's policy advocacy on dental product regulation is undertaken by the team within the ADIA whom receive advice and guidance from employees of member businesses serving on the ADIA-PRPC Product Regulation Policy Committee. Member updates are provided at the quarterly series of ADIA State Branch Briefings.
Further Information —
For further information on ADIA's dental product regulation policy advocacy send an email to email@example.com or telephone 1300 943 094. To keep up to date follow ADIA on Facebook at www.facebook.com/dental.industry or subscribe to the Twitter feed @AusDental.
Currency Of Information & Disclaimer —
This update was issued on 3 February 2018 and please note that changes in circumstances after the publication of material or information may impact upon its accuracy and also change regulatory compliance obligations. The statements, regulatory and technical information contained herein are believed to be accurate and are provided for information purposes only. Readers are responsible for assessing its relevance and verifying the accuracy of the content. To the fullest extent permitted by law, ADIA will not be liable for any loss, damage, cost or expense incurred in relation to or arising as a result of relying on the information presented here.
This information is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, other images and where otherwise stated.
|A —.. A D I A . .S T R A T G E G I C . .A L L I A N C E S
|* To download these files you'll need ADIA Member Plus access.
14th May 18
A Senate Report has recommended that the Australian Government place licensing requirements for the supply, ownership and operation of diagnostic imaging equipment on the agenda for consideration by the Council of Australian Government
8th May 18
Local manufacturers and importers of dental laboratory products are being urged to step-up and meet their legal obligations by reporting their activities to the Therapeutic Goods Administration (TGA).