Australia is a highly attractive market for medical device manufacturers, but gaining access requires navigating the TGA's rigorous registration process. This step-by-step guide covers the full pathway to ARTG inclusion, from device classification and Sponsor obligations through to Manufacturer Evidence, application submission, and audit preparation, with practical guidance on costs and timelines.
Selling a medical device in Australia requires approval from the Therapeutic Goods Administration (TGA). Medical devices and IVDs must be included in the Australian Register of Therapeutic Goods (ARTG), which requires proof of conformity with TGA standards.
It’s a rigorous process, as TGA’s regulatory framework, Essential Principles, classification rules, and documentation procedures have become nearly synonymous with requirements under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). However, this means Australia registration is especially seamless for manufacturers leveraging CE Marking.
In this in-depth guide, we’ll walk you through the Australia TGA medical device registration process, step by step.
There are two main regulatory pathways: a full TGA Conformity Assessment, or an Abridged pathway that leverages prior approval from one of TGA's accepted reference markets (EU, US, Canada, Japan, Singapore and Medical Device Single Audit Program (MDSAP) Auditing Organizations). Foreign Manufacturers must also appoint an Australia-based legal entity called an Australian Sponsor to act as the local regulatory representative and submit applications on their behalf.
Key steps in the Australia TGA registration process
Some of the steps required for the Australia medical device registration process include:
All manufacturers must proactively engage in post-market activities and obligations (e.g., record keeping and post-market monitoring) and pay annual feels to maintain ARTG inclusion. However, this article will focus on pre-market registration requirements.
Classifying your medical device or IVD according to TGA’s rules is the first step in the registration process because it determines everything you need to do to register your device: available regulatory pathways, specific documentation needed from an overseas regulator (if you are pursuing that route), review timelines, audit selection potential, and review timelines and costs.
The Therapeutic Goods Act 1989 established the definition of a medical device that applies in Australia. As in most markets, this definition is intentionally broad and can include Software as a Medical Device (SaMD) and accessories.
If your product is regulated as a medical device in other major markets, it probably qualifies as a medical device in Australia. If you haven’t already done so, confirm your device meets the definition of a medical device using TGA’s medical device determination tool. TGA also maintains guidance on boundary and combination products where there may be ambiguity as to a product’s designation as a device, medicine, or biological.
Australia's medical device classification closely aligns with the European Union (EU MDR/IVDR) rules. TGA has also been consistent in mirroring the EU’s reclassification of certain high-risk devices and software. If you are leveraging CE Marking, you can expect the same classification under TGA rules, but it is always wise to do a formal classification assessment. Australia has separate classification rules and guidance for medical devices, active implantable medical devices, and IVDs.
Manufacturers leveraging FDA approval should be prepared for discrepancies between TGA and FDA classification. FDA does not differentiate between low- and high-moderate-risk devices (versus EU’s Class IIa and IIb approach). Also, TGA's rules-based system contains more granularity than FDA’s predicate system. As such, manufacturers of borderline high-risk devices, AI- or software-enabled devices, and active implantable devices are more likely to be up-classified in Australia compared to the FDA.
Classification of IVDs: Class 1, 2, 3, and 4
IVDs are classified according to classification rules in Schedule 2A of the Therapeutic Goods (Medical Devices) Regulations 2002 (TGA provides an in-depth explanation of how to apply the rules on its website). Like the EU, IVDs are classified into four classes from lowest to highest risk:
IVD classification is determined primarily by the intended use and the potential consequences of an incorrect result to a patient or public health. For instance, a false negative for a blood-borne disease in a patient or donor screening context is a higher risk scenario than an inaccurate result from a general chemistry analyzer.
Classification of General Medical Devices: Class I, IIa, IIb, and III
For all other medical devices that are not IVDs, the TGA uses a four-tier classification system under Schedule 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (TGA provides an in-depth explanation of how to apply the rules on its website). Classification rules consider the duration of contact with the body, whether the device is invasive or non-invasive, whether it is active, and which part of the body it contacts.
Active devices are classified according to the same tier structure (I, IIa, IIb, III); however, separate classification guidance for active devices is available to clarify how the rules apply to these products.
Before submitting an application to the TGA, sponsors and manufacturers must ensure several foundational requirements are in place: appointing an Australian Sponsor, securing Manufacturer Evidence (ME) (i.e., proof of sufficient Good Manufacturing Practice (GMP) compliance), and assembling the necessary technical and clinical documentation.
Every foreign medical device sold in Australia must have an Australian Sponsor, a legal entity (company or individual) based in Australia who takes regulatory responsibility for the device. The sponsor acts as the primary point of contact with the TGA. Therefore, foreign manufacturers must retain and establish a formal agreement with a Sponsor based in Australia prior to placing their devices on the market
The Sponsor’s core responsibilities include:
The Sponsor also bears primary legal accountability for the device's compliance once it enters the Australian market and can face significant penalties for non-compliance.
Manufacturer Evidence (ME) is the TGA's formal recognition that the manufacturer’s QMS has been formally assessed as adequate for the type of device it manufactures. ME is a separate, prerequisite application that must be approved by the TGA before an ARTG inclusion application can be submitted (Class I self-certified devices are exempt).
The sponsor submits an ME application through the TBS portal on behalf of the foreign manufacturer that includes proof of GMP compliance, and the TGA assesses it as a standalone process. Once valid ME is in place and linked to the manufacturer, the sponsor will receive a Manufacturer Evidence Identifier. The sponsor can then proceed with the ARTG application.
Acceptable forms of Manufacturer Evidence include:
TGA will reject ME applications if your submitted evidence is not accepted for your device class, so refer to Use of Market Authorisation Evidence from Comparable Overseas Regulators guidance document (Table 2) for a detailed breakdown of accepted ME documentation by device class and reference authority. If your ME documentation is not in English, you must provide a certified translation.
A detailed explanation of how to submit ME through TBS is available on the TGA website. There is no fee for the ME application.
Exact documentation requirements vary by device class, but the following documents are required for most applications.
Core documents required for all applications:
Specific conformity assessment documents depend on your classification and overseas regulator. For instance, if you are leveraging an FDA 510(k), additional documentation will include your 510(k) decision summary to supplement your QMS documentation (MDSAP certificate).
The TGA recommends Medical Device Regulatory Engagement Meetings (also called pre-submission meetings) for Class III devices, novel devices, and new technologies. These meetings are free of charge and allow you to discuss your evidence, intended purpose, and classification questions directly with TGA staff before submission.
Most overseas manufacturers leverage conformity assessment from a TGA-recognized overseas body (usually a European Notified Body under the EU MDR/IVDR) as part of the Manufacturer Evidence submission. However, there are situations in which a TGA Conformity Assessment Certificate (CAC) is still required. For example, if you are an Australian-based manufacturer or your overseas conformity assessment certification is not accepted by TGA, you will need to obtain a TGA CAC before submitting your ARTG application.
Pre-submission meetings are strongly encouraged before applying for a TGA CAC. These meetings help clarify the appropriate application pathway, identify gaps in supporting documentation, and set expectations on timeframes.
Applications are submitted through the TBA portal. Supporting evidence in the form of a technical file or design dossier depending on device classification must be provided with the application fee.
Once submitted, the application moves through the following stages:
Total time, including applicant response periods, typically ranges from 10 to 15 months for new applications. Applications that require Advisory Committee on Medical Devices (ACMD) input or an on-site audit can take 12–16 months.
With your Manufacturer Evidence accepted and supporting documentation in order, you are ready to apply for ARTG inclusion. All ARTG applications are submitted electronically through the TBS portal. The Sponsor must be registered on the portal before an application can be submitted.
Setting up and using TBS:
Submitting an ARTG Application:
Your application will result in one of four outcomes: inclusion in the ARTG, selection for audit, refusal, or withdrawal. If included, you will receive an automated email confirming you can begin supplying the device. If selected for audit, you will be asked to provide more information and, for mandatory audits, pay an assessment fee. Refusal means your application was rejected, and you will need to resubmit it for further consideration. Application fees are non-refundable in all outcomes.
A TGA application audit is a formal review in which the TGA requests supporting documentation from a sponsor to verify that a medical device meets Australia's regulatory requirements. Some devices are automatically selected for an application audit (“mandatory audit”) based on their intended use or classification. However, TGA can initiate an application audit (“non-mandatory audit”) of any device application at any point during its review.
Application audits are carried out in two levels of depth and scrutiny:
A Level 1 audit can evolve into a Level 2 audit if reviewers deem it necessary and vice versa.
If your application is selected for an audit or requires a mandatory audit, TGA will send a formal letter to the Sponsor outlining the required documentation, the applicable fee, and the deadline for response. Failure to provide the required documentation by the TGA's specified deadline can cause your application to lapse. In general, manufacturers should be prepared to respond within approximately 20 working days.
Some devices are automatically selected for an application audit based on their intended use or classification. Mandatory audit selection criteria target high-risk devices leveraging reference approval under the US FDA or EU Medical Device Directive (MDD), In Vitro Diagnostic Directive (IVDD), or Active Implantable Device Direction (AIMDD).
Non-mandatory audits are usually triggered for applications fitting one or more of these key criteria:
A more detailed explanation of TGA’s mandatory and non-mandatory audit selection criteria is available on its website. However, it is worth noting that TGA can select an application for an audit for any reason at any point in the review process.
The application audit requires a complete, stand-alone submission package. TGA will not accept cross-references to previous or in-progress applications. TGA examines several key areas of your submission, including:
For higher-risk devices, the TGA will expect considerably more detail across each section of the technical file, particularly clinical evidence. If you are leveraging an EC Certificate, you may also need to provide your Performance Evaluation or Clinical Evaluation Report and risk management file. If using FDA clearance without an MDSAP certificate, be prepared for a more involved submission, as there is less congruence between FDA and TGA documentation requirements.
Even if you expect an audit, you must wait for formal notification from the TGA before submitting your audit package, as the notification letter will include specific documentation requirements. However, you can prepare by ensuring your technical file is audit-ready, conformity assessment evidence is current and appropriate for the device classification, and all labeling and IFU documents are complete and compliant.
TGA fees are indexed annually and can change each year. Sponsors should always refer to the current fee schedule. As a baseline, TGA charges fees for ARTG applications due on submission and annual ARTG listing fees. Listing fees must be paid in September of each year to keep your listing active. Annual and application fees range from less than $1000 for Class I devices and less than $2000 for Class IIa-III devices.
However, other TGA activities required to support your ARTG listing can drive up the cost significantly. For instance, if your submission requires a mandatory application audit, your application costs will rise to five figures. Manufacturers who need a TGA Conformity Assessment certificate are looking at considerably higher registration costs associated with the conformity assessment process, as TGA CACs for high-risk devices can cost over six figures. A full regulatory roadmap assessment is necessary to accurately estimate your costs, especially for moderate- to high-risk devices.
The TGA publishes its average turnaround times for application reviews on its website each year, but it is important to understand that these are “targets.” Individual, real-world timelines can differ based on application volume and TGA resources. Your overall time to market can shift depending on the quality of your application, if your application requires an audit, or if you pursue TGA conformity assessment.
Approximate TGA Review Timelines for General Medical Devices:
Approximate TGA Review Timelines for IVDs:
For manufacturers already holding CE marking under the EU MDR or IVDR, Australia registration is one of the more accessible market expansions available. The alignment between the two frameworks means that much of your existing technical documentation, clinical evidence, and QMS infrastructure can be leveraged directly. For manufacturers whose primary approval is from other reference markets, specifically the FDA, a more careful gap assessment is advisable, particularly for higher-risk devices where classification differences and documentation requirements can create additional work.
Regardless of your starting point, a qualified Australian Sponsor is essential. Pure Global can act as your Sponsor and identify the strongest regulatory strategy for your product. We will assess your documentation for any gaps and help you navigate an application audit if necessary. Learn more about medical device and IVD registration in Australia.
Explore our collection of articles, success stories, and regulatory updates, designed to help you take your product global.
Whether looking for more information or ready to partner with us, we're here to guide you through every step of the regulatory process.
Contact us(1).jpg)
.jpg)
