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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3D Printed Products - Industry Leads Regulatory Reform

3D Printed Products - Industry Leads Regulatory Reform

11th Dec 17

Summary —

The dental industry is leading the charge in development of new regulatory standards for 3D printed medical devices with the aim of allowing the sector to adopt this pioneering new technology as it evolves.

Key Issues For The Dental Industry —

Australia’s dental industry has proven itself to be an early adopter of 3D printed medical devices which has lead the Therapeutic Goods Administration (TGA) to engage extensively with the Australian Dental Industry Association (ADIA) concerning the development of an appropriate regulatory framework.

As discussions between ADIA and TGA have continued there is an agreed understanding that the current medical device regulatory framework may not adequately mitigate risks to patients.  This isn’t surprising as the current medical device regulatory framework was developed in an era when 3D healthcare products – especially implantable medical devices – was not on the horizon of anyone at that stage.

After extensive consultation with ADIA and other industry associations representing medical device manufacturers, the TGA has set out its broad direction with respect to the regulation of 3D printed medical devices.  This is set out in a discussion paper downloadable via the link below:

TGA Consultation Paper —

. 3D Printed Medical Devices Regulatory Change [PDF]

The dental industry’s position has been developed by manufacturers and suppliers serving on the ADIA-PRPC Product Regulation Policy Committee and the ADIA-LIG Laboratory Interest Group.  This has developed broad agreement on the following points:

3D Printing Dental Industry Perspective ―

The current custom-made medical device framework does not provide a sufficient degree of protection for some high-risk 3D printed medical devices;
The regulatory framework should be agnostic with respect to technology so as to encompass not only additive manufacturing processes (e.g. 3D printing) but also subtractive manufacturing processes (e.g. milling);
The regulations should also recognise that 3D printing can be used for patient-specific medical devices but also small-scale reproduction of identical medical devices;
Dental laboratories producing large number of custom-made medical devices should continue to be considered as a ‘manufacturer’ for regulatory purposes; and
Dental prosthetists and dentists producing custom-made medical devices for their own practices should not be considered a ‘manufacturer’ for regulatory purposes, so long as their equipment and manufacturing inputs are listed on the TGA Australian Register of Therapeutic Products, the list of medical devices that can be lawfully supplied in Australia.

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As can be expected in the development of a new regulatory framework for an emerging technology, the TGA has been exploring a number of options.  The TGA has demonstrated a strong commitment to work with ADIA to ensure that the new regulations are based on a risk management approach designed to ensure public health and safety, while at the same time freeing industry from any unnecessary regulatory burden.

In working with the TGA, the position of ADIA has been to ensure that the new regulatory framework is agnostic as to the technology, thus allowing 3D printing processes to use different technology including material jetting, binder jetting, powder bed fusion, directed energy disposition, sheet lamination and vat photopolymerisation.  ADIA is also with working with the TGA to ensure that the new regulatory framework is suited to existing technologies such as milling.

The collaboration between dental industry and the TGA on this matter underpins the important role that ADIA plays as a trusted source of policy advice to government as the latter comes to terms with pioneering new patient diagnostic and treatment options.

Member Engagement —

ADIA’s work in supporting the adoption of dental product regulatory standards that support innovation while preserving patient safety is coordinated by members serving on the ADIA-PRPC Product Regulation Policy Committee and the ADIA-LIG Laboratory Interest group.  They provide advice and guidance to the policy team in the ADIA National Office.

Further Information —

For further information from ADIA's on matters associated with research on the market for dental products send an email to statistics@adia.org.au or telephone 1300 943 094.  To keep up to date follow ADIA on Facebook at www.facebook.com/dental.industry or subscribe to the Twitter feed @AusDental.

Currency Of Information & Disclaimer —

This update was issued on 11 December 2017 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.

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