Overseas manufacturers need an Australian-based sponsor to supply medical devices in Australia. MEDAGENT Australia acts as your local TGA contact, supports applications for inclusion in the Australian Register of Therapeutic Goods and coordinates ongoing regulatory responsibilities after market entry.
What is an Australian Medical Device Sponsor?
The sponsor is the person or company legally responsible for supplying, importing or exporting a medical device in Australia. For most devices, the sponsor applies for inclusion in the Australian Register of Therapeutic Goods before the product can be supplied.
The sponsor is also the primary link between the manufacturer and the Therapeutic Goods Administration. It must be able to obtain information from the manufacturer and respond to regulatory requests within the required timeframe.
