Medical Device Registration in Australia Overview
In Australia, the Therapeutic Goods Administration (TGA) oversees medical devices, including software-based ones or those requiring specific hardware to function correctly. Software, including mobile apps, is considered a medical device if it meets the definition outlined in Section 41BD of the Therapeutic Goods Act 1989 unless specified otherwise. SaMD (Software as a Medical Device) must be registered with the Australian Register of Therapeutic Goods (ARTG) before being legally sold in Australia unless exempt.
On February 25, 2021, the TGA implemented amendments to the regulation of software-based medical devices, and certain software-based medical devices were exempted (by exemption or exclusion) from the scope of TGA regulation. These revisions applied to a wide spectrum of software, including SaMD, which works as a medical device on its own.
Freyr has an in-house office in Australia with SaMD consulting to streamline the approval process. Our medical device Regulatory experts can help you navigate the TGA's Regulatory requirements. Freyr ensures a seamless and effective registration procedure for SaMDs, from the initial assessment to the compilation of relevant documentation and submissions. For expert assistance, contact Freyr's specialists.
Freyr SaMD Registration Australia TGA Competencies:
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Assist in risk classification for SaMD Registration as per Australia’s TGA Regulatory requirements.![]()
Support in obtaining a conformity assessment certificate.![]()
Australian TGA sponsor services.![]()
Facilitate in applying for inclusion on the Australian Register of Therapeutic Goods (ARTG).![]()
Comprehensive technical file preparation.![]()
Ensure end-to-end support through pre and post-device approval by ARTG.![]()
Maintaining robust Quality Management System (QMS).
Frequently Asked Questions (FAQs)
The changes included the following:
- Clarifying the boundaries of regulated software products, including 'carve-outs.'
- Introducing new classification rules.
- Updating key principles to better articulate requirements for software-based medical devices.
Effective February 25, 2021, certain software-based medical devices that were excluded from the TGA regulations are:
- Consumer health products like blood glucose monitors, thermometers, and pulse oximeters.
- Enabling technology, for example, software that transforms a tablet into a heart rate monitor.
- Digitisation tools, for example, software that transforms a stethoscope into a digital stethoscope.
- General wellness and educational apps such as calorie counting and sleep monitoring applications.
- Population based analytics which is used by public agencies and researchers, it is not allowed for consumer use.
- Laboratory information management systems are used in labs to manage studies and information and are not used for individual consumers.
Sponsor is a term that appears frequently in the TGA Australia rules. A software ‘sponsor' is a person or company that does one (01) or more of the following:
- Exports a software-based medical gadget from Australia.
- Imports a software-based medical gadget into Australia.
- Builds (develops) a software-based medical gadget for distribution in Australia or elsewhere.
- Arranges for another party to import, export, or manufacture (create) a software-based medical equipment.
The sponsor must be an Australian resident or a lawfully constituted body (a legal entity in its own right) based in Australia that conducts business there and has an Australian representation.
If you produce and supply software in Australia, you could be both the sponsor and the manufacturer/developer. Alternatively, you may be the software manufacturer/developer but not the sponsor; in this situation, you may have distribution agreements with various sponsors.
The software must be tested and validated before being registered with the TGA and included in the Australian Register of Therapeutic Goods (ARTG) for sale in Australia.
If changes are made to the software after it has been registered, the TGA must be notified of the changes. It may be necessary to recheck the classification. If the revisions indicate that the software's classification has changed, it may be necessary to reapply for registration under the new classification.
Medical Device Regulatory Consulting – Proven Expertise
Why Freyr?
- Independent Representation and Regulatory Support for SaMD products in Australia.
- Continuous Liaison with the TGA for Submissions, Queries, and Feedback.
- Single Point of Contact (POC) for all interactions with the TGA (Therapeutic Goods Administration), the Regulatory agency in Australia.
