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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Priority Pathway To Fast-Track Medical Device Listing

Priority Pathway To Fast-Track Medical Device Listing

2nd Dec 16

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Summary —

The Therapeutic Goods Administration (TGA) is seeking feedback from dental product manufacturers and suppliers on the consultation paper for accelerated assessment of medical devices, otherwise known as the Priority Review pathway.

Key Issues For Consideration —

As part of an ongoing, comprehensive review of the TGA regulatory framework, industry members are invited to provide feedback on a range of reforms which will allow for more efficient and effective assessment for dental devices.

The Expert Panel Review of Medicines and Medical Devices Regulations 2016 recommended a Priority Review pathway be established for “novel” devices. Under the TGA’s proposed guidelines, a device would need to meet the following criteria:

 

1.

The medical device is intended for the prevention, diagnosis or treatment of a life threatening or seriously debilitating disease or condition;

 

2.

The medical device addresses an unmet clinical need in Australian patients;

 

3.

Meets at least one of the following conditions:

 

 

the device represents a breakthrough technology with evidence of a major clinical advantage over existing technology, OR Therapeutic Goods Administration Accelerated assessment of medical devices

 

 

there is evidence that the device offers a major clinical advantage over existing alternatives included in the ARTG

 

 

in the case of in vitro devices (IVDs) ONLY, early availability in Australia will result in a major public health benefit.

The priority review pathway will require medical devices to meet the essential principles, including clinical evidence requirements, while expediting assessment through administrative changes. Development of this pathway also will require the establishment of business process for applications for priority review status. The consultation paper outlines proposed business processes and timeframes and can be downloaded from the following link.

 

TGA Reform Consultation Paper —

Accelerated assessment of medical devices - Priority Review pathway [PDF]

The proposed criteria have been developed with reference to those in place for the US Food and Drug Administration (US FDA).

The Australian Dental Industry Association (ADIA) has unequivocally endorsed the recommendations of the review panel and the Federal Government’s commitment to meeting them. 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 advocacy@adia.org.au not later than 4 January 2017. Your comments will be used to help frame ADIA’s response to this TGA consultation.

Member Engagement —

Employees of ADIA member businesses come together under the auspices of the ADIA-DRC Dental Regulation Committee to review opportunities to strengthen the regulatory framework for the manufacturer and supply of dental products and provide advice and guidance to ADIA staff responsible for policy advocacy.  Members are able to receive updates at the ADIA State Branch Briefings held each quarter.

Currency of Information —

This update was issued on 2 December 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.

Disclaimer —

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. 

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