The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a consultation paper describing proposed changes to the regulation of personalized medical devices. As mentioned in our previous article...
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, including medical devices, has announced public consultations on proposed improvements to the Therapeutic Goods Advertising Code (No.2) 2018, the...
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of healthcare products, has published a consultation paper dedicated to the proposed refinements to the regulation of personalized medical devices. Table of Contents...
The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare products, has published an official notice on conformity assessment bodies. According to the notice, starting July 1, 2021, entities based in Australia may apply...
The Therapeutic Goods Administration (TGA), the Australian regulating authority responsible for healthcare products, has published a guidance document describing transitional rules on reclassification of active implantable medical devices (AIMD). The regulatory...
The Therapeutic Goods Administration (TGA), the Australian regulating authority in the sphere of medical devices, has published guidance dedicated to certificates of free sale and export certificates. The document describes in detail the eligibility criteria and how...
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Australia and Oceania
