ARTG Registration Guidance

Navigating the regulatory landscape of medical devices in Australia can be complex, but understanding the inclusion process in the Australian Register of Therapeutic Goods (ARTG) is crucial for manufacturers and sponsors. The Therapeutic Goods Administration (TGA) governs this process to ensure that all medical devices meet stringent safety, quality, and efficacy standards before being legally supplied in the Australian market. This step-by-step guide clarifies how to determine if your product qualifies as a medical device, the documentation requirements, application procedures, and key considerations involved in getting your product included in the ARTG. We’ll start by defining ARTG.

What is the ARTG?

The Australian Register of Therapeutic Goods (ARTG) is an official database managed by the Therapeutic Goods Administration (TGA) that lists all therapeutic goods legally supplied in Australia. It serves as a central registry for medicines, medical devices, biologicals, and related products that have passed rigorous evaluation to meet Australia’s safety and regulatory standards. Products listed on the ARTG can legally be imported, marketed, or sold in Australia, and registration is mandatory unless exempted by specific legislation. The ARTG also provides transparency by including key details such as product classification, sponsor information, manufacturer data, and ongoing compliance status, making it a vital element in the regulatory framework for therapeutic goods in Australia.

Inclusion in ARTG Database

First, the interested party shall check whether the product subject to review should be included in the ARTG. For this purpose, the interested party shall determine whether the product:

• Is a general medical device, an in vitro diagnostic medical device, or not a medical device at all;
• Falls within the scope of any of the exclusions or exemptions;
• Is a therapeutic product but not a medical device.

In order to determine whether the product in question should be traded as a medical device, the responsible entity shall check whether it meets the definition of a medical device as set forth by the Therapeutic Goods (Articles that are Medical Devices) Specification 2014. Additionally, the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020 declares certain products to be medical devices, primarily starting materials and components used in the dental and allied health sectors, which must be included in the ARTG. Both instruments should be consulted when assessing whether a product requires inclusion.

It is important to ensure that all documentation accompanying the product, including its labeling and instructions for use, as well as any advertising materials contain the correct indication of the intended purpose. Should an entity change the intended purpose of a product, such an entity should be treated as a medical device manufacturer.

Hence, it will have to comply with any and all applicable regulatory requirements. Certain products are excluded from mandatory inclusion in the ARTG. The applicable exclusion criteria are prescribed by the Therapeutic Goods (Excluded Goods) Determination 2018.

Some of the products are also exempted from inclusion in the register. Such products include ones that are:

• Supplied for clinical trials in Australia,
• Prescribed by authorized prescribers,
• Supplied under the Special Access Scheme,
• Imported for personal use under the Personal Importation Scheme, or
• Custom-made medical devices, noting that this exemption now applies only to genuinely bespoke, one-off devices designed and manufactured for individual patients with unique anatomical, physiological, or pathological features for whom no standard device would be suitable. Patient-matched medical devices, those produced within a standardized, reproducible design process are no longer exempt and must be included in the ARTG, or
• Prescription spectacle lenses supplied solely for refractive correction, which are exempt from the requirement for inclusion in the ARTG prior to import, export, or supply in Australia (effective 15 June 2024).

Should the product in question fall within the scope of any exclusion or exemption set forth by the applicable legislation, such a product should not be treated as a medical device.

ARTG Conformity and Review

According to the recommendations provided by the TGA, before applying for inclusion of its medical device in the ARTG, an interested party shall consider several key aspects associated with the product, such as:

• Where the medical device in question should be subject to conformity assessment. An interested party shall indicate the proper class of a medical device in accordance with the applicable risk-based classification and provide the necessary conformity assessment documentation. In certain cases, a TGA Conformity Assessment Certificate may be required. Manufacturers should note that the accepted forms of Manufacturer Evidence have been expanded and now include EU CE Marking certificates, MDSAP certificates combined with market authorization from the US FDA, Health Canada, or Japan MHLW/PMDA, and registration with Singapore’s Health Sciences Authority (HSA). The full list of accepted evidence is set out in Schedules 1 and 2 of the Therapeutic Goods (Medical Devices-Information that Must Accompany Application for Inclusion) Determination 2018, as amended.
• An entity intended to place medical devices on the Australian market should meet the applicable eligibility criteria. For instance, it should be based in Australia in order to be allowed as a sponsor – a party placing medical devices on the market and being responsible for it thereafter. In this regard, a sponsor shall also have in place all necessary documentation for a medical device to be provided by its manufacturer, including the documents confirming that the device subject to review complies with the applicable regulatory requirements and thus could be allowed for marketing and use in the country.
• Application for inclusion in the ARTG related to low-risk medical devices could cover more than one medical device. The authority allows the inclusion of several devices of the same kind in one application in order to reduce the regulatory burden and streamline the process.
• Eligibility for Priority Review designation. In certain cases, a medical device could be eligible for a Priority Review designation – in such a case, the application for its inclusion in the ARTG would have higher status.
• Some applications will be subject to a mandatory audit carried out by the TGA. From July 1, 2024, mandatory audits apply to Class III medical devices and a specific group of IVD devices only; certain previously audited device categories, including device disinfectants and contraceptives, were removed from the mandatory list. Where an application is selected for audit, the applicant will have to provide additional documentation. Note that the TGA may still select any application for a non-mandatory audit at its discretion, though no audit fee applies in those cases.
• Unique Device Identification (UDI) obligations. The UDI regulatory framework came into effect on March 24, 2025, requiring UDI carriers on device labels and packaging, mandatory submission of UDI data to the Australian Unique Device Identification Database (AusUDID), and direct marking for certain reusable devices. Compliance is being phased in by device risk class, beginning with Class III and Class IIb devices, which must meet labelling and data submission requirements by July 1, 2026. Lower-risk device classes follow in subsequent years through to 2030. Sponsors and manufacturers should assess their UDI obligations early and prepare UDI records well in advance of their applicable compliance date.
• Reclassification applications. Sponsors of ARTG entries affected by recent classification changes must submit reclassification applications before 1 July 2026. Affected sponsors may continue to supply under their existing ARTG entries in the meantime, unless the reclassification application is unsuccessful.
• Software and AI-based products. The TGA has clarified that software and AI tools, including clinical decision support tools and digital scribes that suggest diagnoses or treatments, may qualify as medical devices and require ARTG inclusion. Software is considered a medical device when it performs a function such as diagnosis, treatment, or influencing clinical decisions based on patient-specific data. Software used only for general wellness, administrative purposes, or the display of non-clinical information that does not impact patient care is not regulated as a medical device. Developers and suppliers of software or AI-enabled products should assess their products against TGA guidance before supplying in Australia.

ARTG Regulatory Application Requirements

According to the applicable regulatory requirements, the application for inclusion in the ARTG should be submitted in electronic format. For this purpose, the applicant shall obtain a Client ID in order to be able to use the TBS website.

When applying for the services for the first time, the interested party shall provide all necessary information by completing the Organization Details form. In response, the regulating authority will provide a Client Identification number assigned to the applicant.

This number should be used for all further communications with the regulating authority. The TGA additionally emphasizes the importance of keeping valid the information regarding the authorized person entitled to act on behalf of an entity, as it will be the primary point of contact for the TGA.

The contact information the authority will use includes the postal and email addresses, contact phone numbers for the company in general and the contact person in particular, as well as references to the authorized persons indicated by the company.

Describe how the application for inclusion in the ARTG should be submitted with regard to various medical devices, including Class I non-sterile, non-measuring, and Class 1 IVD medical devices; Class 1 general and in vitro diagnostic medical devices intended to be exported from Australia; and medical devices of all the classes except those mentioned above respectively.

Printing the ARTG certificate of inclusion.

The TGA could refuse applications submitted for the inclusion of a medical device in the ARTG if they do not pass the preliminary assessment, are selected for an audit, or are withdrawn by the applicant itself. Should the application meet all the applicable requirements, the TGA will proceed with adding the medical device to the ARTG. Under the general rule, an applicant will be informed about the decision taken with regard to its application within 20 business days starting from the date the applicable fee has been paid.

Upon successful completion of the inclusion process, the applicant will be able to print a certificate confirming that the medical device in question has been included in the ARTG. This could be performed via the TBS website.

In summary, this guidance describes the process of inclusion in the Australian Register of Therapeutic Goods as it stands in 2026. Key developments since the original October 2025 version include: the narrowing of the custom-made device exemption; the new prescription spectacle lens exemption; expanded Manufacturer Evidence options; simplified mandatory audit rules; the live UDI framework with Class III and IIb compliance due 1 July 2026; a reclassification application deadline of July 1, 2026; and TGA clarification on when software and AI products require ARTG inclusion. Sponsors and manufacturers should consult the TGA website directly for the most current legislative instruments and guidance, as this is an active area of regulatory development.

Sources:

https://www.tga.gov.au/publication/medical-device-inclusion-process

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