A Comprehensive Guide to TGA and Medical Device Registration in Australia

Before any medical device can be supplied in Australia, it must be included in the Australian Register of Therapeutic Goods (ARTG), which is regulated by the Therapeutic Goods Administration (TGA).

Device Classification in Australia

The TGA uses a four-tier risk-based classification system: Classes I (including sterile and measuring), IIa, IIb, and III, with regulatory control increasing alongside risk. Australian rules closely mirror the EU criteria, so classification in Australia usually matches that of the EU.

Registration

Companies that already have CE Marking often find the TGA process straightforward, because Australia recognizes European conformity. Nevertheless, every device must still be registered with the TGA and receive an ARTG listing number; some classifications also require a mandatory audit.

Representation for Medical Device Companies

Firms without an Australian office must appoint an in-country representative, called an Australian Sponsor. The Sponsor handles ARTG listing and post-market obligations such as adverse-event reporting and recalls; their name and contact details must appear on the device label.

Experienced consultants can assess TGA requirements, identify appropriate GMDN codes, compile or review the clinical summary, and submit applications on your behalf.

• Assess the Australian TGA registration requirements for your device(s).
• Research the proper GMDN codes for your medical device(s).
• Assist with compilation or review of the clinical summary required by the TGA.
• Submit device applications to the TGA.

This information is educational and not a substitute for professional regulatory advice.

TGA overview