3D printed medical devices—ADIA leads regulatory reform

3D printed medical devices
Copyright: kjpargeter / 123RF Stock Photo

The Australian Dental Industry Association is leading the charge in supporting the Therapeutic Goods Administration (TGA) to 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 led the TGA to engage extensively with ADIA this matter,” ADIA CEO Troy Williams said.

“We have a shared objective of ensuring that new regulations do not unnecessarily constrain this evolving technology.”

As discussions between ADIA 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,” Williams said.

In working with the TGA, ADIA’s position has been to ensure that the new regulatory framework is not just suited to existing technologies such as milling but takes into account various 3D printing processes including material jetting, binder jetting, powder bed fusion, directed energy disposition, sheet lamination and vat photopolymerisation.

“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,” Williams said.

“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.”

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