How does the TGA classify medical devices?

The TGA classifies medical devices into categories such as Class I, IIa, IIb, III, and AIMD. This classification system is largely harmonized with the European Union (EU) medical device regulations.

Does the TGA accept overseas conformity assessments?

Yes, the TGA accepts certain overseas conformity assessments, including EU MDR CE certificates issued by designated notified bodies and certifications from the Medical Device Single Audit Program (MDSAP). This streamlines the regulatory process for some international manufacturers.

All terms

RegulatoryRegulated Pathways Global MarketsTGA

Therapeutic Goods Administration

Australia's regulator for therapeutic goods including medical devices and IVDs.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

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.

What the regulation says

The Therapeutic Goods Administration (TGA) is Australia's regulatory body for therapeutic goods, including medical devices. It operates under the Therapeutic Goods Act 1989, ensuring that medical devices supplied in Australia are safe and perform as intended; this aligns with international regulatory principles for medical device oversight.

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.

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.

Frequently asked questions

The ARTG is a public database of all therapeutic goods, including medical devices, that can be legally supplied in Australia. Devices must be listed on the ARTG to be marketed in the country.

Cross-references

Uses

Concepts or artefacts this term builds on.

Medical Device Single Audit Program(MDSAP)

Grouped by theme

Editor's picks

· Hand-selected related concepts

Regulatory

EU Medical Device Regulation(MDR)

Regulation (EU) 2017/745 governing medical devices in the European Union.

Regulatory

Unique Device Identification(UDI)

System for adequate identification of medical devices through distribution and use.

Quality & Risk

Medical Device Single Audit Program(MDSAP)

Single audit of a manufacturer's QMS satisfying multiple participating regulators.

More in Regulatory

· Same category

Regulatory

510(k) Premarket Notification(510(k))

FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.

Regulatory

510(k) Summary vs 510(k) Statement

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.

Regulatory

513(g) Request for Information(513(g))

Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.

Regulatory

Abbreviated 510(k)

510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.

Primary references

3 sources

Link health: 3 verified· last checked 2026-06-20

TGA·1IMDRF·1RAPS·1

Inline markers like [1] jump to the matching reference above.

On this term

Category: Regulatory
Acronym: TGA
Sources: 3
Updated: 5/5/2026

Compare with another term

Learn in 60 seconds

Australia's regulator for therapeutic goods including medical devices and IVDs.

·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.
·Devices are classified I, IIa, IIb, III, or AIMD using rules aligned with the EU framework.

Remember this

Watch out: A common pitfall is misunderstanding the specific classification rules used by the TGA, which, while aligned with the EU framework, may have national nuances.

Related terms

You may also need

Auto-suggested from Regulatory and shared keywords.

All Regulatory terms

From the Blue Goat network

Related resources and services on this topic.