www.3ders.org

Nov 10, 2017 | By Benedict

Australia's Therapeutic Goods Administration (TGA) is looking at changing regulations on personalized 3D printed medical devices. A consultation was launched on Thursday, with some believing Australia could be off the pace in terms of 3D printing innovation.

Researchers and businesses are constantly finding new ways to leverage additive manufacturing for medical purposes. Getting those 3D printed innovations approved for practical use, however, can take a very long time.

In the U.S., the Food and Drug Administration (FDA) has only recently started developing 3D printed medical device guidance that tells companies what’s acceptable and what isn’t. And even with that guidance, it’s still a lengthy process to get a product approved.

In Australia, things are a bit different. At present, any 3D printed device that’s made to fit a patient’s anatomy (and a very large number 3D printed devices fit this description) is classed as a custom-made medical device—even if the device is based on a mass-produced “template” that receives only a few tweaks to fit an individual patient.

This has prompted the country’s Therapeutic Goods Administration (TGA) to call for a big rethink on how it approaches personalized 3D printed medical devices.

Because in reality, a medical device company’s 3D printed prosthetic (or a product of this sort) that can be made to fit a patient’s anatomy isn’t always a custom-made device in the traditional sense. That is, it’s not being created on the spot for a completely unique case; it’s just being slightly reshaped or resized to fit a patient.

Proposed new regulations would re-classify these kinds of 3D printed medical devices as patient-matched devices that would be regulated like regular medical devices, which would eliminate the need for medical professionals to request certain conformity assessments for individual items.

3D printers used to make these individual medical devices would receive a similar classification, moving customized 3D printed medical devices and the equipment used to make them into a different category altogether.

The TGA has also proposed four other changes to regulations. The first of these involves stricter regulations on (genuine) one-off medical devices, making manufacturers of these devices provide more information to both patients and the TGA.

Another proposal involves changing the definition of a “medical device manufacturer” to exclude entities like hospitals, which would allow hospitals to use approved medical device production systems for low/moderate-risk devices (Class IIa and lower) without manufacturer certification.

Additionally, the TGA proposes classifying both anatomical models and the software used to make them as Class IIa devices, which would increase the burden of requirements on manufacturers of these medical models. Again, hospitals and healthcare providers would be exempt.

Finally, the TGA plans to classify devices that contain a human tissue component (but are not completely made from human tissue) as Class III devices—rather than their existing classification as “biologics.” The U.S., E.U. and Canada already take a similar approach.

The TGA is seeking comments from concerned parties about its proposals, and will consider any comments submitted before December 22, 2017.

Back in August, the Australian Dental Industry Association (ADIA) began reviewing its regulations around 3D printed dental products.

 

 

Posted in 3D Printing Application

 

 

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