Minister Asked To Delay New TGA Charges
11th Apr 18
As the Therapeutic Goods Administration (TGA) acts to introduce an application fee for placing Class 1 medical devices on the Australian Register of Therapeutic Goods (ARTG), ADIA has meet with senior ministerial advisors in order to seek an outcome to alleviate the impact on the dental industry.
Key Issues For The Dental Industry —
Consistent with the TGA's cost-recovery model where its activities are funded by fees charged to its regulated entities, the regulator has proposed to introduce a fee of $530 to place Class 1 medical devices on the ARTG.
When the proposal was first outlined by the TGA the Australian Dental Industry Association (ADIA) sought, and as a result of extensive consultation between the TGA and ADIA, was provided with information that outlined the methodology used to determine how the proposed $530 fee was calculated. As a result of these consultations there is confidence that an appropriate level of robustness has been applied.
The outcomes of the TGA’s proposal directly increases the regulatory compliance burden on SMEs in the sector and provides a new financial barrier to the entry of new and innovative dental products. It is estimated that for these small businesses the cost will be between $4,240 and $13,250 per year, a significant new impact on businesses that turn over less than $2.5m per year.
The timing of the new fee, this being an introduction date of 1 July 2018, is viewed as particularly problematic as it affects commercial decisions already made and being actioned by business in circumstances where no fee had been flagged. For this reason, ADIA met in Parliament House with senior staff from the Health Minister's office to canvass a delay of twelve months that would result in an introduction date of 1 July 2019.
ADIA's discussions with the TGA and the Minister for Health remain ongoing.
Member Engagement —
On matters associated with medical device regulation and the work of the TGA the team in the ADIA National Office responsible for policy advocacy receive advice and guidance from members serving on the ADIA-PRPC Product Regulation Policy Committee.
Further Information —
To keep up to date on matters associated with how TGA fees and charges affect the dental industry 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 firstname.lastname@example.org or by telephone telephone on 1300 943 094.
Currency Of Information & Disclaimer —
This update was issued on 11 April 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
5th Mar 18
The TGA is proposing to levy for the first time an application fee for placing Class 1 medical devices on the Australian Register of Therapeutic Goods (ARTG), a proposal that will significantly add business compliance costs.
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