Australian TGA Sponsor

Medical device and IVD manufacturers based outside Australia are required to appoint an In-Country Representative, known as an Australian Sponsor or Australian TGA Sponsor, who will include your devices in the Australian Register of Therapeutic Goods (ARTG). This TGA Sponsor assumes a critical role in both the device registration process and post-market compliance activities. Hence, it is vital to choose a highly competent and independent representative. MDSS AU Pty Ltd, with its physical presence in Sydney, Australia, offers comprehensive Australian TGA Sponsor services to aid manufacturers of Medical Devices and IVDs in navigating the ARTG registration process for their devices.

As specified by the Therapeutic Goods Act 1989 and Therapeutic Goods (Medical Devices) Regulations 2002, the Sponsor serves as the liaison between the manufacturer and the Therapeutic Goods Administration (TGA). The Sponsor takes on regulatory representation for your devices within the Australian market and undertakes the responsibility of registering the devices with the TGA.