Feedback Needed To Slash Red Tape On Medical Devices
17th Nov 16
Feedback from the dental industry is sought on proposed Therapeutic Goods Administration (TGA) regulatory reforms that will increase the use of medical device assessments from comparable overseas regulators and enable the establishment of commercial bodies in Australia to assess the same.
Key Issues For Consideration —
As part of a comprehensive review of the TGA regulatory framework, advice from industry is being sought on reforms that will increase flexibility in pre-market assessment processes for medical devices. This will be achieved by enabling the establishment of commercial bodies in Australia designated to undertake medical device assessments, and increasing the use of assessments from comparable overseas regulators.
The proposed reforms were set out in Recommendation 15(2) of the March 2015 report of the Medicine and Medical Devices Review (MMDR). Recommendation 16 also relates to designation of Australian conformity assessment bodies. The recommendations were accepted by Government and are endorsed by the Australian Dental Industry Association (ADIA).
In response to the reforms to establishment of commercial bodies in Australia designated to undertake medical device assessments , the TGA has sought advice on the proposed implementation of a system to designate bodies to undertake conformity assessment certification of medical devices, including in vitro diagnostic medical devices (IVDs) for the Australian market. For further information, download the following consultation document:
TGA Reform Consultation Paper ―
Designation of Australian conformity assessment bodies for medical devices [PDF]
The implementation proposal is similar to that in the European Union whereby there could be multiple bodies, designated by TGA, that are able to undertake conformity assessment certification within Australia. Medical devices certified by these bodies would not undergo application audit by the TGA when applying for inclusion in the Australian Register of Therapeutic Goods (ARTG). These designated bodies could potentially be designated to undertake conformity assessments for all classes of devices or for certain devices only.
Development of this pathway will require the establishment of standards for technical and clinical competence and governance (including management of conflict of interest) which such bodies would need to meet in order to be designated. The removal of the need for an application audit could mean potential saving for industry of 6 months and earlier access for consumers.
To ensure that ADIA is able to make detailed representations on behalf of dental product manufacturers and suppliers, the advice of member businesses is sought and should be submitted via email to firstname.lastname@example.org not later than 4 January 2017. Your comments will be used to help frame ADIA’s response to this TGA consultation.
Currency of Information —
This update was issued on 17 November 2016 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, other images and where otherwise stated.
22nd Aug 18
If your business is regulated by ASIC it may be required to submit information to the the Australian Government that will be used to determine the fees that will be paid. The reporting deadline is 27 September 2017.
9th Apr 18
The Australian Government has released new guidance as to how the Therapeutic Goods Administration (TGA) implements cost recovery activities associated with the regulation of medicines and medical devices.