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TGA INFORMATION     


Please be advised, our organisations routinely construct devices using specified articles that are listed within the ARTG (Accordingly, these devices qualify for an exemption from listing the device seperately within the ARTG). In the circumstance, that an imported component is used in the construction of a device, we have registered transition, and will register these devices within the ARTG as required by the TGA and government legislation.

https://www.tga.gov.au/how-we-regulate/supply-therapeutic-good/supply-medical-device/medical-devices-reforms/medical-devices-reforms-personalised-medical-devices

Please be assured that we are 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.

Follow the link here to find documentation regarding the materials, components and specified articles used in the construction of our devices.

If you have any questions in relation to this, or how it might affect you, please do not hesitate to contact us directly.

Regards
DentalBiz Group Chatswood
(MJ Dental, Rodwell Orthodontic Lab, Young Orthodontic Lab, Zan Orthodontic Lab)