Australia TGA Medical Device Registration: ARTG Inclusion, Sponsor and Overseas Evidence

Australia is often the easiest market to add after the United States, the EU, Canada and the UK, because the Therapeutic Goods Administration (TGA) is built around reliance on evidence that already exists. If you hold a CE certificate, an FDA clearance or an MDSAP certificate, you may be able to reuse much of it. But Australia still has its own legal entity requirement, its own classification, its own register and its own post-market duties. This guide explains how a medical device gets onto the Australian Register of Therapeutic Goods (ARTG), which overseas evidence the TGA can use, and what stays your responsibility afterwards.

The legal framework in brief

Medical devices in Australia are regulated under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002. The regulator publishes the Australian Regulatory Guidelines for Medical Devices (ARGMD), which explain classification, conformity assessment and the use of overseas evidence. Software, including software as a medical device, falls in the same framework with additional classification rules for software-based devices. If your product is SaMD, read our guide on whether software is a medical device as well.

Classification

Class	Risk	Examples
I	Low (including Class I sterile and Class I measuring sub-groups)	Bandages, reusable surgical instruments, simple measuring devices
IIa	Low to medium	Hypodermic needles, dental materials
IIb	Medium to high	Ventilators, bone fixation products
III	High	Heart valves, certain implants
AIMD	Active implantable medical device	Pacemakers, implantable stimulators

The classification rules are close to the EU rules, which is one reason EU evidence maps well. Always check the Australian rule for your device, because small differences (for example in software, or in measuring and sterile Class I sub-groups) change the evidence you need. Our overview of device classification shows how to compare systems.

The Australian sponsor

A sponsor is an Australian person or company that supplies the device in Australia, or exports it from Australia, or arranges for either. The sponsor applies for ARTG inclusion, holds the entry and carries legal responsibility toward the TGA. For an overseas manufacturer this is typically a local distributor, a subsidiary or a specialist regulatory service provider.

• The sponsor must be able to obtain the manufacturer’s evidence on request, including during a TGA audit or a recall.
• The manufacturer should keep control of the technical documentation, and the contract should cover access, change notification, complaints and vigilance.
• If the sponsor relationship ends, the ARTG entry cannot simply move: plan the transfer.

Conformity assessment and overseas evidence

Before applying, the manufacturer must have appropriate conformity assessment evidence that the device meets the Essential Principles of safety and performance. The TGA does not always run its own full assessment. For many devices it uses evidence from comparable overseas regulators to abridge or replace parts of its assessment. The accepted sources include:

• EU notified body certificates under the MDD, AIMDD and the MDR (and the IVD directives and IVDR for IVDs).
• UK Approved Body certificates under the UK regulations.
• MDSAP certificates and audit reports, provided the audit scope covered the Australian requirements. See ISO 13485 and MDSAP audit readiness.
• US FDA approvals and clearances: PMA, 510(k) and De Novo decisions.
• Health Canada medical device licences.
• Japanese (MHLW and PMDA) approvals or certification.
• Singapore HSA registrations.

General conditions apply to every route: the evidence must be for the same device or device group with the same design, intended purpose, users and indications; the certificate must be issued to the manufacturer named on the labelling; documents that are not in English need a certified translation; and the TGA can audit any application, with Class IIb and Class III applications more likely to be selected. The exact combination of evidence you need depends on class, so read the current TGA guidance on using overseas evidence before you commit.

Evidence by class, in outline

Class	Typical evidence pattern
I (non-sterile, non-measuring)	Manufacturer’s declaration of conformity; no overseas certificate required
I sterile or measuring	Certificate or evidence covering the sterile or measuring aspects, such as an EU or UK certificate
IIa	QMS evidence (for example MDSAP) plus product-level evidence where relevant
IIb	QMS evidence plus product evidence such as a Health Canada licence, an FDA 510(k) or De Novo summary or an EU type examination
III and AIMD	As for IIb with design examination and type examination evidence, or an FDA PMA or Health Canada Class IV licence in some routes

The ARTG application step by step

1. Classify the device under the Australian rules and confirm whether it is an IVD or a device, and whether any special category applies (software, medicines-containing, tissue-containing).
2. Appoint the Australian sponsor and get access to the TGA’s business services.
3. Collect the conformity assessment evidence and check that the certificate scope matches the product, the manufacturer name and the intended purpose.
4. Prepare the Declaration of Conformity and the supporting documents. The manufacturer’s declaration must cover the Essential Principles and the chosen conformity assessment procedure.
5. Submit the application through the TGA system and pay the application fee. Applications that are selected for audit have additional fees and timelines.
6. Respond to any audit request within the deadline, supplying the technical documentation and QMS evidence.
7. Receive the ARTG entry and keep it current: pay annual charges and notify changes.

Fees and charges

Costs have three parts: the application fee, the application audit fee when an audit applies, and an annual charge per ARTG entry that depends on class. The TGA updates its fees and charges each financial year (effective 1 July), so check the current schedule before you budget. Charges per entry are low for Class I (other) and rise for Class IIa, IIb, III and AIMD. Because the annual charge is per entry, grouping similar devices in one entry where the rules allow it can reduce cost.

After inclusion: sponsor and manufacturer duties

• Adverse event reporting: the sponsor reports certain adverse events to the TGA within set timeframes, and the manufacturer must supply the information. Align your global vigilance process with Australia: see post-market surveillance.
• Recalls and safety actions: recalls are coordinated through the sponsor and the TGA’s recall system. Our guide to recalls and field safety corrective actions covers the common process.
• Changes: some changes need a variation or a new application. Include Australia in your change control impact assessment.
• Certificate expiry: an ARTG entry that relies on an overseas certificate can be affected when that certificate expires, is suspended or is withdrawn. Track the validity dates.
• Unique device identification: Australia is developing its UDI system. Follow current TGA announcements and see our UDI guide for the principles.

Common mistakes

• Relying on a certificate that does not cover the same device, variant or intended purpose.
• Using an MDSAP certificate that did not include Australia in the audit scope.
• Choosing a sponsor only on price, then finding it cannot support audit or recall requests.
• Not translating non-English evidence with certification.
• Letting an overseas certificate expire without telling the sponsor.
• Assuming Class I devices need no documentation. A declaration of conformity and a technical file are still required.

Frequently asked questions

Can I register a device in Australia without an Australian company?

No. The application is made by an Australian sponsor. The sponsor can be a distributor, a subsidiary or a regulatory service provider, but it must be an Australian entity.

Does a CE mark or FDA clearance get me an ARTG entry automatically?

No, but it can be used as evidence in the application. The evidence must match the device and manufacturer, and the application still needs to be made and accepted.

Is MDSAP required?

It is not the only route, but an MDSAP certificate that covers the Australian requirements is one of the most efficient forms of QMS evidence, especially for classes IIa and above.

How long does inclusion take?

It depends on class and on whether the application is audited. Straightforward applications that use accepted overseas evidence can be processed much faster than audited applications. Ask your sponsor for the current service standards.

Do the same rules apply to IVDs?

IVDs have their own classes and conditions, including special rules for self-tests and companion diagnostics. Our IVDR guide explains the EU system that many IVD manufacturers use as evidence.

TGA rules, fees and accepted evidence change from time to time. Confirm current requirements on the TGA website and with your Australian sponsor before you act on this guide.

Related reading

• Global market access beyond the US and EU: compare Australia with other markets.
• ISO 13485 and MDSAP audit readiness: build evidence that several regulators accept.
• Health Canada medical device licence: another reliance-friendly market.
• UK medical device regulation: UKCA, CE recognition and MHRA registration.
• RAC (Devices) study material: covers TGA and other global systems.

Talk to the AptSkill team

Planning an Australian launch or building global regulatory skills? Send us your device type, target markets and goal.