ADIA is the peak business organisation representing manufacturers and suppliers of dental products. Our vision is for an industry that empowers oral health professionals to advance the health and wellbeing of all Australians...................... — ADIA Strategic Plan

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TGA Fee Reduction Supports Dental Product Exporters

TGA Fee Reduction Supports Dental Product Exporters

15th Oct 18

Summary —

A change to the way the Therapeutic Goods Administration (TGA) calculates fees for placing products on the register of medical devices that can be lawfully supplied will support dental product exporters.

Key Issues For The Dental Industry —

The Therapeutic Goods Administration (TGA) maintains the Australian Register of Therapeutic Goods (ARTG), the list of therapeutic products that can be lawfully supplied in Australia.  The cost of operating the ARTG is met by the fees the TGA levies on businesses to place entries on the register and maintain these each year.  In a significant outcome for businesses in the dental industry that export products, the TGA has reduced the fee for making an application for low-risk (Class 1 – Export Only) entries.

The current fee to place a low-risk (Class 1 – Export Only) medical device on the ARTG is $530; however, this will retrospectively fall to $90 from 1 July 2018.  The Australian Dental Industry Association (ADIA) has welcomed this move given that it supports businesses in the dental industry that create jobs through exports.

The most recent introduction of the fee is particularly welcome in the context of the fact that it increased significantly earlier this year as part of a broader package of reforms to the TGA’s fees for low-risk medical devices.  As ADIA engaged with the Australian Government on the fee increases in early 2018, it secured a commitment that the TGA would review its approach to maintaining the ARTG and where cost savings could be identified these would be passed on to business.  The TGA reviewed the way it manages new entries for low-risk (Class 1 – Export Only) and was able to change its processes that resulted in the change.

The TGA has advised ADIA that an opportunity has also been identified to streamline the processing of applications for low-risk (Class 1 – Export Only) medical devices by modifying the TGA’s software so that when a business makes an application to place these on the ARTG they are automatically included.  This requires the business making the entry to now take full responsibility for the correctness of the information included in the application.

The great news for ADIA member businesses is that the change is retrospective and those businesses that may have already paid the $530 fee for making a low-risk (Class 1 – Export Only) entry on the ARTG will have the difference ($440) exported.

ADIA will meet with the TGA in early December 2018 to negotiate fees and charges for the coming year.

Further Information —

The ADIA Policy Team negotiating with the Australian Government on matters of dental product regulation receive advice and guidance from members serving on the ADIA-PRPC Product Regulation Policy Committee.

Further Information —

To keep up to date with all matters associated with dental product regulation follow ADIA on Facebook at www.facebook.com/dental.industry or the Twitter feed @AusDental. For further information on ADIA's engagement with the TGA on fees and charges send an email to policy@adia.org.au or telephone 1300 943 093.

Currency & Disclaimer —

This update was issued on 15 October 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, other images and where otherwise stated. 

A.. A D I A . .S T R A T E G I C . .A L L I A N C E S
 

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