ARTG Registration Australia

Looking to bring your medical device to the Australian market? Understanding how ARTG registration works is a key part of the process. The Therapeutic Goods Administration (TGA) oversees this in Australia, and the first thing you’ll need to do is figure out the right classification for your device. From low-risk items like bandages to high-risk ones like pacemakers, every product has its place. Once classified, you’ll need an Australian sponsor, prepare the technical documents, and go through the proper steps—like submitting a Declaration of Conformity and possibly a design dossier, depending on the device class.

After all documents are reviewed and approved by the TGA, you’ll get an ARTG registration number. This allows you to legally sell your medical device in Australia. The listing stays valid as long as your product remains unchanged, your CE Marking is current, and you pay the annual fee. If you’re not sure where to start, getting help from a regulatory consultant like Vicki Partridge can make the whole process easier. With years of experience dealing with the TGA, she can guide you through every step. Read more