Medical devices must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in, imported into, or exported from Australia, unless exempt from being entered in the ARTG, or otherwise authorised by the TGA.
The Therapeutic Goods Act, Regulations and Orders set out the requirements for inclusion of therapeutic goods in the ARTRG, including advertising, labelling, product appearance and appeal guidelines. Some provisions such as the scheduling of substances and the safe storage of therapeutic goods, are covered by the relevant State or Territory legislation. Australian legislation in full text is available from the Attorney General’s Federal Register of Legislation.
Market Access (AUS) Pty Ltd provides agent services for applications for inclusion in the ARTG (i.e., the TGA market authorisation process). If you would like to discuss your needs for including your medical device in the ARTG, please contact Günther Theisz at firstname.lastname@example.org or use our general enquiries email: email@example.com.