TGA (Therapeutic Goods Administration, Australia)
Australia's regulatory authority for therapeutic goods including medical devices. TGA manages the Australian Register of Therapeutic Goods (ARTG) and requires devices to be included on the ARTG before they can be supplied in Australia.
The Therapeutic Goods Administration (TGA) is the Australian government authority responsible for evaluating and monitoring therapeutic goods, including medical devices, pharmaceuticals, and biologics. All medical devices must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be legally imported, exported, manufactured, or supplied in Australia.
TGA classification and registration
TGA classifies medical devices into five categories: Class I, Class I (measuring/sterile), Class IIa, Class IIb, and Class III — aligned with the Global Harmonization Task Force (GHTF) framework. Australian sponsors (importers or manufacturers) must apply for ARTG inclusion, providing conformity assessment evidence. TGA recognizes certain international certifications (e.g., EU Notified Body certificates), which can streamline the registration process.
TGA in procurement
Australian hospital tenders require valid ARTG inclusion as a mandatory compliance criterion. Procurement teams verify ARTG numbers through the TGA's public database. Suppliers must ensure their ARTG entries are current and accurately reflect the device models being offered in tender responses.