3D Printed Products – Industry Leads Regulatory Reform

The Australian Dental Industry Association (ADIA) is leading the charge in supporting the Therapeutic Goods Administration (TGA) develop new regulatory standards for 3D printed medical devices.

“Australia’s dental industry has proven itself to be an early adopter of 3D printed medical devices which has lead the TGA to engage extensively with ADIA this matter. We have a shared objective of ensuring that new regulations do not unnecessarily constrain this evolving technology,” said Troy Williams, ADIA Chief Executive Officer.

As discussions between ADIA, the peak business organisation representing dental product manufacturers and suppliers, and the TGA have continued, a shared understanding has developed 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 back then,” Mr Williams said.

IIn 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 various 3D printing processes 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 dental industry has proven itself, both within Australia and globally, to be an early adopter of pioneering patient diagnostic and patient treatment options. It’s in this context we’re working with the TGA to ensure that new regulations do not constrain use of new technologies,” Mr Williams said.

The ADIA membership is working on the dental industry’s response to a TGA consultation paper outlining regulatory reform options, with the two organisations meeting frequently to discuss the matter.

“In our engagement with the TGA the dental industry’s objective is to develop a regulatory framework for 3D printed medical devices that is 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,” Mr Williams concluded.

ADIA Background Information
Founded in 1925, the Australian Dental Industry Association (ADIA) is the peak business organisation representing manufacturers and suppliers of dental products.  Active in each mainland state and with a strong presence in Canberra, ADIA is a strong advocate for policy reforms that allow member businesses to grow, create jobs and operate sustainably.  ADIA’s vision is for an industry that empowers oral health professionals to advance the health and well-being of all Australians.  The services offered by ADIA that support member businesses include industry statisticstraining programmes and trade shows including ADX Sydney, the nation’s largest healthcare exhibition that attracts some 8,000 stakeholders from across the oral healthcare community.

For further information on ADIA visit the website at: www.adia.org.au.