Therapeutic Goods Administration
Australia's regulator for therapeutic goods including medical devices and IVDs.
Definition
The TGA administers the Therapeutic Goods Act 1989, including the Australian Register of Therapeutic Goods (ARTG). Devices are classified I, IIa, IIb, III, or AIMD using rules aligned with the EU framework. Most devices must be entered on the ARTG by a local Australian sponsor before supply. To reduce duplication, the TGA can accept conformity assessment evidence from comparable overseas regulators, including EU notified body certificates and MDSAP audit reports.What this means in practice
TGA accepts certain overseas conformity assessments (e.g., EU MDR CE certificates from designated bodies, MDSAP). Sponsors must hold the ARTG entry and meet Australian Unique Device Identification (UDI) requirements as they roll out.Examples
- A European manufacturer with a Class IIb device holding a valid EU MDR CE certificate can leverage this certification to support their application for ARTG inclusion with the TGA.
- A US-based company seeking to introduce a new Class III implantable device in Australia must ensure it meets TGA's classification criteria and undergoes the appropriate conformity assessment procedures for ARTG entry.
- A medical device sponsor in Australia needs to ensure their device information, including UDI, is accurately maintained on the ARTG once registration is achieved.
- •A common pitfall is misunderstanding the specific classification rules used by the TGA, which, while aligned with the EU framework, may have national nuances.
- •Manufacturers sometimes fail to properly navigate the process of obtaining and maintaining an entry in the Australian Register of Therapeutic Goods (ARTG).
- •Assuming that EU CE certification automatically guarantees market access in Australia without further TGA specific requirements is a frequent mistake.
- •Not staying updated on the evolving Australian Unique Device Identification (UDI) requirements can lead to non-compliance.
Frequently asked questions
Cross-references
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/745 governing medical devices in the European Union.
System for adequate identification of medical devices through distribution and use.
Single audit of a manufacturer's QMS satisfying multiple participating regulators.
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· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
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Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1TGA Medical DevicesTier 2 VerifiedTGAtga.gov.au
- 2IMDRF DocumentsTier 2 VerifiedIMDRFimdrf.org
- 3RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
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