On May 20, 2026, the Therapeutic Goods Administration (TGA) published guidance explaining how sponsors can apply for consent to import, supply, or export medical devices that do not comply with Unique Device Identification (UDI)-related Essential Principles in Australia. The guidance outlines the UDI-related Essential Principles, the consent application process, and a reduced fee structure that will take effect from July 1, 2026. The streamlined process applies only to applications relating solely to UDI-related Essential Principles. Applications involving both UDI and non-UDI Essential Principles must continue to use the standard Consent to Supply (CtS) process and pay the standard application fee. The TGA also clarified that the streamlined approval process and reduced fees will not be available for UDI CtS applications submitted before July 1, 2026. The guidance applies to various medical device categories, including implantable devices, in vitro diagnostic devices, personal protective equipment, personalized medical devices, software, and artificial intelligence-based medical devices.
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