TGA Updates Regulatory Framework for 3D-Printed, Personalized Medical Devices

Australia’s Therapeutic Goods Administration is proposing five changes to its regulatory approach for 3D-printed and personalized medical devices to reflect the rapid technological advancements over the past two decades.

“The idea that a hospital would be able to use a ‘printer’ to manufacture an implant for a particular patient’s anatomy would have been considered impossible in the not too distant past; but it is a reality today,” the TGA said, in a consultation paper.

The agency is inviting comments on the following proposed changes:

• Changing the definition of custom-made medical devices to be inclusive of 3D-printed patient-specific devices, and adding new definitions for customized medical device; patient-specific medical device, personalized medical device, mass produced medical devices and medical device production system;
• Adding new requirements for manufacturers to the conformity assessment procedure for custom-made devices, such as providing a statement about a device to the patient receiving it; and allow TGA to inspect facilities that produce custom-made devices;
• Changing the definition of a manufacturer to clarify that producers of customized devices, such as healthcare providers, are not required to meet the same regulatory requirements of manufacturers because they are not defined as such;
• Redefining diagnostic imaging recording devices to add “software and anatomical models intended for diagnosis or investigation of the anatomy” to the classification; and
• Reclassifying devices with human material as Class III medical devices, rather than biologicals, to be better aligned with other jurisdictions like Europe and Canada.

TGA called on stakerholders for feedback on the proposed regulatory changes to address any potential unintended consequence.

Read the consultation paper here: www.fdanews.com/11-10-17-Consultation.pdf.