Regulatory
Therapeutic Goods Administration(TGA)
In one line
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.
Why it matters
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.
Common pitfalls
- •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.
Sources
- TGA Medical Devices · TGA
- IMDRF Documents · IMDRF
- RAPS Regulatory Focus · RAPS