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TGA Guidance on Considerations for Medical Devices
The Therapeutic Goods Administration (TGA), a division of Australia’s Department of Health responsible for medical devices circulation, issues new guidance dedicated to the evidence requirements. The new guidance...
TGA Consultation Paper on Fees and Charges
The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical device and medicinal product regulation, issued a consultation paper dedicated to the fees and charges associated with the...
TGA Guidance on IVD Companion Diagnostics
The Therapeutic Goods Administration (TGA), the division of the Australian Department of Health responsible for medical device regulation, issues guidance on IVD companion diagnostic devices. Definition of IVD...