Glenn Street Enterprises provides Australian sponsor representation for overseas medical device manufacturers seeking Australian market access, with a direct interface to the TGA.
An Australian sponsor is the local party responsible to the TGA for a medical device supplied in Australia. For overseas manufacturers, the sponsor is the point of contact for ARTG inclusions, regulatory correspondence, and ongoing sponsor obligations.
GSE provides statutory sponsor representation under the Therapeutic Goods Act, including acting as sponsor of record and maintaining the documentation required for those obligations.
GSE can act as your Australian sponsor and, where required, manage the related regulatory work. Related TGA, ARTG, documentation, labelling and quality work is described on our Services page.
ARTG inclusion is the beginning of Australian supply, not the end of the regulatory relationship. Where appropriate, GSE continues to support TGA post-market compliance, reporting obligations, and related documentation after inclusion.
If you already have an Australian sponsor and are considering a change, contact GSE to discuss your circumstances. We will review the matter before advising whether we can assist.
Initial 30-minute consultations are complimentary and without obligation. We will review your circumstances and assess next steps.