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). According to the Therapeutic Goods (Medical Device - Specified articles) Instrument 2020, our Patient matched Medical Devices (PMMD) will qualify for an exemption, meaning our devices do not generally require seperate inclusion within the ARTG. In the circumstance, that a component is not already ARTG included, we have provided a notification 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 certified materials, components and techniques available. Over the transition period we will remain vigilant and ensure we are compliant with the Therapeutic Goods (Medical Devices) Regulations 2002 including the requirement to comply with the Medical Device "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). According to the Therapeutic Goods (Medical Device - Specified articles) Instrument 2020, our Patient matched Medical Devices (PMMD) will qualify for an exemption, meaning our devices do not generally require seperate inclusion within the ARTG. In the circumstance, that a component is not already ARTG included, we have provided a notification 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 safety. We continue to use the very best certified materials, components and techniques available. Over the transition period we will remain vigilant and ensure we are compliant with the Therapeutic Goods (Medical Devices) Regulations 2002 including the requirement to comply with the Medical Device "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