ARTG Inclusion Support for Medical Devices and IVDs

Compliance Management Solutions supports medical device and IVD manufacturers through ARTG inclusion, from classification and technical documentation to the TGA submission and any application audit that follows. We work with overseas manufacturers, for whom we can also act as Australian sponsor, and with Australian manufacturers and sponsors preparing their own applications.

Talk to us about your device Call +61 4 33 124 266

What ARTG inclusion means

The Australian Register of Therapeutic Goods (ARTG) is the public database of therapeutic goods that can be legally supplied in Australia. The TGA's position is that most medical devices need to be included in the ARTG before they can be supplied, and the application is made by the device's Australian sponsor.

Not every product needs an entry. Some are excluded from regulation altogether. Others are medical devices but exempt from inclusion, such as devices supplied for clinical trials, under the Special Access Scheme or by authorised prescribers, and custom-made devices. Some of those exemptions still require notification to, or approval from, the TGA, so it is worth confirming where your product sits before anything else.

How we help

Regulatory strategy and pathway. We help you assess your device and identify the regulatory pathway that applies, including how it is classified and which evidence you already hold can be used.
Technical documentation. We develop regulator-ready technical files covering the device description and specification, intended purpose, indications and contraindications, ISO 14971 risk management, labelling and IFU, and Essential Principles compliance.
Clinical and supporting evidence. Clinical evaluation and performance evaluation support, biocompatibility and pre-clinical evidence planning, and usability engineering documentation.
ARTG inclusion support and regulatory submissions, including manufacturer evidence and the inclusion application, with direct communication with the TGA throughout.
Application audits. Documentation prepared to be complete, compliant and audit ready, and regulatory correspondence with the TGA if your application is selected.
Quality management systems. Where your device needs a certified quality management system, we help with ISO 13485 implementation.

The inclusion process, step by step

The TGA sets out the steps to supply for device sponsors. In short:

Confirm the product needs an ARTG entry, and is not excluded or exempt.
Classify the device. The manufacturer is responsible for classification, and the TGA does not refund fees for an application made in the wrong class.
Assemble the evidence. Either the manufacturer's Declaration of Conformity (for the lowest-risk categories) or manufacturer evidence accepted by the TGA, which must be in place before the inclusion application can be drafted.
Lodge the application through the TGA Business Services portal and pay the application fee, which is non-refundable.
Preliminary assessment. The TGA must complete this within 20 working days. The outcome is inclusion, selection for audit, or refusal.
Inclusion. The device receives an ARTG number and the certificate of inclusion can be printed from the portal.
Keep the entry current for as long as the device is supplied.

What evidence each class needs

Non-IVD medical devices are classified from Class I to Class III, and IVDs from Class 1 to Class 4, by the risk they present. The class sets the minimum evidence the TGA needs to see.

Device	Evidence for the ARTG application
Class I, not supplied sterile and without a measuring function	Manufacturer's Declaration of Conformity
Class 1 IVD	Manufacturer's Declaration of Conformity
Class I supplied sterile or with a measuring function	Manufacturer evidence accepted by the TGA
Class IIa, IIb and III	Manufacturer evidence accepted by the TGA, from a TGA conformity assessment certificate or a comparable overseas regulator
Class 2, 3 and 4 IVDs	Manufacturer evidence accepted by the TGA

For every device, the manufacturer must be able to demonstrate compliance with the Essential Principles, and the sponsor must hold that evidence or be able to obtain it on request. Which conformity assessment procedure produces that evidence is covered on our TGA conformity assessment page.

Using approvals you already have

The TGA recognises assessments from comparable overseas regulators: EU notified bodies under the EU MDR and IVDR, the US FDA, Health Canada, MDSAP auditing organisations, Japan's MHLW and PMDA, Singapore's HSA and UK approved bodies. Two points catch applicants out:

It must be the same device. The overseas evidence has to be for the device you are applying to include, with the same design, intended purpose and indications.
An MDSAP certificate must cover Australia. A common reason manufacturer evidence is unsuccessful is an MDSAP certificate that does not show the manufacturer was assessed against the relevant parts of the Australian medical device regulations.

There is no TGA fee for a manufacturer evidence application, and the TGA aims to process them within 15 working days.

Application audits

After preliminary assessment, an application can be selected for audit. Some applications must be audited by law, and those carry an audit fee. Others are selected against the TGA's criteria, with no audit fee.

Level 1 audits do not need specialist assessment. They check matters such as labelling, instructions for use, patient information, classification and conformity assessment documents.
Level 2 audits usually need specialist assessment, such as clinical, software, engineering, biomaterials or microbiology. All IVD audits are Level 2.

Audit	TGA target timeframe
Level 1	50 working days
Non-mandatory Level 2 or IVD	150 working days
Mandatory Level 2 or IVD	180 working days

These targets were introduced in September 2025, replacing the TGA's earlier 60 working day target. They include the 20 working day preliminary assessment and exclude any time the TGA spends waiting for your answers. If deficiencies are found you will usually have 20 to 40 business days to respond, and application and assessment fees are not refunded if an application is withdrawn or refused. Complete documentation at lodgement is the most effective way to limit how long an audit takes.

How long ARTG inclusion takes

The TGA does not publish a single end-to-end figure. The clock is the 20 working day preliminary assessment, plus the audit timeframe if the application is selected, plus however long it takes to answer the TGA's questions. For eligible devices addressing serious conditions and unmet clinical needs, the priority review pathway offers front-of-queue assessment. For a fuller picture, see how long ARTG inclusion takes in Australia.

One ARTG entry or several

Applications are made for a kind of medical device. Devices are of the same kind when they share the same sponsor, manufacturer, classification and GMDN code, and, for Class III, active implantable (AIMD) and most Class 4 IVD devices, the same unique product identifier. Class III and AIMD devices can also carry variants, such as different sizes or lengths, on one entry where the variation does not change the intended purpose. Getting the grouping right at the start avoids paying for entries you did not need, or finding later that one entry cannot cover a product.

After inclusion

An ARTG entry has to stay accurate. The TGA expects a variation when, for example, the manufacturer's details, the GMDN code, the intended purpose, the variants or the manufacturer evidence change, and a change to the unique product identifier can mean a new entry. The sponsor must notify the TGA within 60 days if the manufacturer evidence behind an entry is suspended, revoked or lapses. Unique Device Identification requirements began on 1 July 2026, starting with Class IIb and Class III devices. For the ongoing obligations of the sponsor role, see our TGA sponsor page.

Start with a pathway review

Frequently asked questions

Does every medical device need to be included in the ARTG?

Most do. The TGA states that most medical devices need to be included in the ARTG before they can be supplied in Australia. Some products are excluded from regulation altogether, and some devices are exempt from inclusion, for example devices supplied for clinical trials, under the Special Access Scheme or by authorised prescribers, and custom-made devices. Some exemptions still require notification to, or approval from, the TGA.

Can a Class I device be self-certified?

A Class I device that is not supplied sterile and does not have a measuring function can be included on the basis of the manufacturer's Declaration of Conformity, as can a Class 1 IVD. Most other devices need manufacturer evidence accepted by the TGA before the inclusion application can be made.

Can we use our European or FDA approval in Australia?

Often, yes. The TGA recognises assessments from comparable overseas regulators, including EU notified bodies under the EU MDR and IVDR, the US FDA, Health Canada, MDSAP auditing organisations, Japan's MHLW and PMDA, Singapore's HSA and UK approved bodies. The evidence must be for the same device, with the same design, intended purpose and indications.

How long does ARTG inclusion take?

The TGA does not publish a single end-to-end timeframe. Every application goes through a preliminary assessment, which the TGA must complete within 20 working days. If the application is selected for audit, the TGA's current targets are 50 working days for a Level 1 audit, 150 for a non-mandatory Level 2 or IVD audit, and 180 for a mandatory Level 2 or IVD audit. Time spent waiting for your responses is not counted.

What happens if our application is selected for audit?

The TGA sends a notice asking for further information and tells you which documents to provide. For a mandatory audit it also invoices the audit fee, and the audit cannot start until it is paid. If deficiencies are found you will usually have 20 to 40 business days to respond. Well prepared technical documentation is the best way to keep an audit short.

Are TGA application fees refundable?

No. The TGA does not review an application until the fee is paid, and it does not refund application or assessment fees if an application is refused or withdrawn. That is why classification and evidence need to be right before you lodge.