Parliament passes medical device reforms
15th Jun 17
Following Australian Dental Industry Association's (ADIA) policy advocacy, parliament has passed legislation that will allow the Therapeutic Goods Administration (TGA) to designate third-party conformity assessment bodies, a move that eases the compliance burden for local dental product manufacturers.
Key Issues For The Dental Industry —
ADIA has welcomed the passage through parliament of legislation that will reduce the red-tape associated with the TGA compliance obligations.
The reforms are contained in the Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016 which was approved by the House of Representatives on 27 March 2017 and subsequently by the Senate on 14 June 2017.
ADIA has been a strong proponent for these reforms that will reduce the costs associated with conformity assessment, the process of making sure medical devices meet TGA’s standards for design and performance.
The change is to be achieved by amending the Therapeutic Goods Act (Cth) 1989 which will allow the Australian Government to designate bodies in Australia to undertake such conformity assessment of manufacturers of medical devices. These new Notified Bodies will provide an alternative avenue, other than the TGA, for manufacturers of medical devices to obtain a conformity assessment certificate required before their medical devices may be included in the Australian Register of Therapeutic Goods (ARTG). Download the legislative amendment from the link below:
Legislative Download —
Therapeutic Goods Amendment (2016 Measures No. 1) Bill 2016
When the Australian Government announced an expert review of medicines and medical device regulation, ADIA used this as an opportunity to argue that reforms were required that would allow the TGA to rely upon the work of third-party conformity assessment bodies. ADIA continued to advocate for this as the Senate Community Affairs Committee undertook an inquiry into this legislation.
ADIA believes that these reforms will streamline regulatory approvals of dental products without compromising the safety and quality. The passage of this legislation is therefore welcome news for ADIA member businesses.
During the course of this year it is expected that Parliament will be presented with two more Bills that will further enhance the medical device regulatory framework. ADIA is currently working with the TGA on the scope of this further reform.
Member Engagement —
On matters associated with dental product regulation the team in the ADIA national office receives advice and guidance from members serving on the ADIA-DRC Dental Regulation Committee. Updates on the research are provided at the quarterly ADIA State Branch Briefings. If your business has an interest in this matter, get involved today.
Further Information —
For further information from ADIA on matters associated with dental product regulation 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 15 June 2017 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 publication is available for your use under a Creative Commons Attribution 3.0 Australia licence, with the exception of the ADIA logo, images and where stated.
19th Mar 18
Collaboration on efforts to support dental product manufacturers and suppliers in Australia and Britain is the key outcome of a new agreement between ADIA and BDIA to be signed this week in Sydney.
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).