Expanding into Australia? Let’s make it happen. For overseas medical device manufacturers, entering the Australian market requires a locally established sponsor. That’s where we come in.
As your Australian Medical Device Sponsor, we simplify regulatory processes, act as your direct link to the Therapeutic Goods Administration (TGA), and support applications for inclusion in the Australian Register of Therapeutic Goods (ARTG). From your first steps into the market to ongoing regulatory responsibilities, we’re here to make your journey smoother, more efficient, and easier to navigate.
What is an Australian TGA Sponsor?
An Australian Medical Device Sponsor is a locally established person or company legally responsible for sponsoring, supplying, importing or exporting medical devices supplied in Australia.
For most medical devices, inclusion in the Australian Register of Therapeutic Goods (ARTG) is required before they can be legally supplied. Your sponsor manages the relevant applications and serves as the primary point of contact between your company and the TGA. But the role doesn’t end with market entry. A sponsor also has ongoing regulatory obligations, including maintaining relevant information, responding to authority requests, and supporting post-market compliance.
With MEDAGENT Australia by your side, you gain a dedicated local partner who understands the regulatory landscape and helps you stay focused on what matters most: bringing your innovations to the Australian market.
