ASBFEO Calls For Delay In Introducing Medical Devices Tax
26th Jun 18
The Australian Small Business and Family Enterprise Ombudsman (ASBFEO) has called for a delay in the introduction of the new medical devices tax so that its impact can be fully assessed.
Key Issues For The Dental Industry —
The Therapeutic Goods Administration (TGA) looks set to implement its new medical devices tax that will hit all businesses looking to place low-risk medical devices on the Australian Register of Therapeutic Goods (ARTG), the list of medicines and medical devices that can be lawfully supplied in Australia. However, the ASBFEO has asked the TGA that the tax be placed on hold until an assessment has taken place to determine if the appropriate Australian Government consultation guidelines have been adhered to.
The TGA must, under guidelines published by the Department of Finance, prepare a Regulation Impact Statement (RIS) when seeking to change policy by introducing a new fee. As part of the standard Australian Government procedure, the TGA would publish the RIS on its website and make this available for public comment. The TGA has not done so.
Similarly, the TGA must consult with industry stakeholders about the content of the Cost Recovery Implementation Statement (CRIS) before the new medical devices tax is placed on its website. Again, the TGA has not done so.
It is in this context that the ASBFEO has asked that the introduction of the new medical devices tax be placed on hold so that a review of the TGA's approach to consultation can be made. A copy of the relevant correspondence can be downloaded below:
The ASBFEO’s intervention comes as a growing coalition of industry associations in the medical devices sector call for the introduction of the new tax to be delayed. These include the Assistive Technology Suppliers Australasia (ATSA), the Optical Distributors & Manufacturers Association (ODMA) and the Australian Medical Devices and Distributors Association (AMDDA) which have joined the Australian Dental Industry Association (ADIA) in calling for proper consultation on the proposed fee.
The ADIA Chief Executive Officer, Troy Williams, has been called to Parliament House this week to provide a further series of briefings as to how this tax will impact the dental industry, and the medical devices sector more broadly.
Member Engagement —
Employees from across ADIA member businesses of all sizes serving on the ADIA-PRPC Product Regulation Policy Committee determine policy priorities on matters associated with dental product regulation. Updates are available to members at the quarterly ADIA State Branch Briefing series.
Further Information —
To keep up to date with matters associated with dental product regulation subscribe to the Twitter feed @AusDental or follow us on Facebook at www.facebook.com/dental.industry. Alternatively, you can contact the Association via email at email@example.com or by telephone on 1300 943 094.
Currency Of Information & Disclaimer —
This update was issued on 25 June 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 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.
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3rd May 18
Proposals from the Australian Government to impose new cost imposts on suppliers of low-risk medical devices will eliminate the entire benefit of its tax cuts for many small businesses in Australia’s dental industry.
11th Apr 18
As the TGA acts to introduce an application fee for placing Class 1 medical devices on the ARTG, ADIA has meet with senior ministerial advisors in order to seek an outcome to alleviate the impact on the dental industry.