TGA Proposes Application Fee For Class 1 Devices
5th Mar 18
The Therapeutic Goods Administration (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 to the compliance costs for business is in the sector.
Key Issues For The Dental Industry —
The TGA operates on a cost-recovery model where its activities are funded by fees charged to its regulated entities. This includes charging to place certain goods on the Australian Register of Therapeutic Goods (ARTG), the list of medicines and medical devices that can be lawfully supplied in Australia.
The TGA requires that, pursuant to the Therapeutic Goods Act 1989 (Cth) that Class 1 medical devices are required to be listed on the ARTG by sponsors before they may be lawfully supplied in Australia. Currently, sponsors use an automated electronic process to have such devices listed on the ARTG. For Class 1 medical devices this does not currently incur a fee or charge.
The TGA has stated that despite the automation it still incurs administrative costs to maintain these entries and associated post-market activities and that, to date, these costs are currently being met through cross-subsidisation by other fees and charges; however, to date the TGA has not quantified the cost of this past subsidisation in FY2017-18 or prior years.
For the first time the TGA proposes to charge an application fee for placing low-risk (defined as Class 1 products) medical devices on the ARTG. The proposed fee is $530. In the context of the TGA’s cost-recovery model the Australian Dental Industry Association (ADIA) has offered its in-principle support for charging a fee; however, a fee of this magnitude is considered to be excessive.
Having consulted with dental product suppliers, and the medical devices sector more broadly, it’s clear that the TGA’s proposed fee will adversely affect the sustainability of business, particularly the SME sector. The result, as identified by the TGA itself, is that the proposed fee provides a financial barrier to the introduction of new and innovative products in the Australian marketplace.
Australia’s dental industry is largely comprised of SMEs that supply low-risk (e.g. Class 1 medical devices) and the impact of the fee will have a disproportionate impact on these businesses.
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 form 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.
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 5 March 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
28th May 18
ADIA has advised a parliamentary enquiry reviewing impediments to business investment how the TGA’s proposed medical devices tax will make it harder for businesses in the dental industry to grow.
2nd Jul 18
Importers of dental laboratory products are being encouraged to review Australia’s regulatory standards to ensure their suppliers are aware of the design and construction principles that protect patient safety.