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TGA INFORMATION     

There are some significant changes occurring relating to TGA regulation of dental appliances. Up to this point "custom-made medical devices" have been exempt from registration on the Australian Register of Therapeutic Goods (ARTG).

From 25th February 2021, TGA regulation and more specifically the re-classification of "custom-made medical devices" requires dental professionals to register with the TGA the various types of dental appliances they provide as categories of "personalised medical devices".

Part of that process is to register with the TGA an intent to access a transitional period for those that provide medical devices (as manufacturers or sponsors). This period allows for transition from 25th February 2021 until 1st November 2024.

https://consultations.health.gov.au/tga/accessing-transition-arrangements-patient-matched/consultation/intro/

Please be assured that our laboratory (and business partners) are absolutely dedicated to you and your patients. We will continue to use the very best materials, components and techniques available. Over this transition period we will remain vigilant and ensure we are compliant to the best of our ability.

Together with the dental sector working group (DSWG), we have been working on the changes being introduced. As part of this, the TGA is currently in the consulation period to address some of our valid concerns.  Please follow the link below to see what refinements have been discussed.

https://www.tga.gov.au/medical-devices-reforms-personalised-medical-devices
https://www.tga.gov.au/personalised-medical-devices-dental-sector-working-group

In due course, we will provide documentation for you to reference. If you have any questions in relation to this, or how it might affect you, please do not hesitate to contact us directly.

Regards David Rodwell

Information for dental professionals