TGA INFORMATION
Please be advised, our organisation routinely constructs devices using materials and components that are already included in the Australian Register of Therapeutic Goods (ARTG) as "specified articles". Accordingly, our Patient Match Medical Devices (PMMD) will qualify for an exemption and therefore do not require a seperate inclusion within the ARTG. In the circumstance, that a component is not already ARTG included, we have registered our intention to transition, and will include these devices within the ARTG as required by the TGA and government legislation in due course. Noting that all PMMD are currently exempt until 1 July 2029.
Please be assured that we are dedicated to you and your patients. We continue to use the very best materials, components and techniques available. Over this transition period we will remain vigilant and ensure we are compliant with the Therapeutic Goods (Medical Devices) Regulations 2002 including the regulations covered in the "Essential Principles".
Follow the link here to find documentation regarding the materials and components 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
TGA INFORMATION
Please be advised, our organisation routinely constructs devices using materials and components that are already included in the Australian Register of Therapeutic Goods (ARTG) as "specified articles". Accordingly, our Patient Match Medical Devices (PMMD) will qualify for an exemption and therefore do not require a seperate inclusion within the ARTG. In the circumstance, that a component is not already ARTG included, we have registered our intention to transition, and will include these devices within the ARTG as required by the TGA and government legislation in due course. Noting that all PMMD are currently exempt until 1 July 2029.
Please be assured that we are dedicated to you and your patients. We continue to use the very best materials, components and techniques available. Over this transition period we will remain vigilant and ensure we are compliant with the Therapeutic Goods (Medical Devices) Regulations 2002 including the regulations covered in the "Essential Principles".
Follow the link here to find documentation regarding the materials and components 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