[Home](/)/[Resources](/resources)/Australia TGA Class I Devices AustraliaMedTech guide # Australia TGA Class I Medical Devices: ARTG Inclusion and Self-Assessment Class I medical devices are the lowest-risk category under Australia's TGA framework — non-sterile, non-measuring devices that follow a self-assessment pathway rather than mandatory third-party conformity assessment. But "self-assessment" does not mean unregulated: Class I devices must comply with the Essential Principles, be included on the ARTG by an Australian sponsor before supply, and maintain post-market obligations for the life of the product. Copy Link[Share on WhatsApp](https://wa.me/?text=https%3A%2F%2Fkrono-labs.com%2Fguides%2Faustralia-tga-class-i-devices) At a glance Class Class I (lowest risk) Registry ARTG Pathway Self-assessment Regulator TGA ## Class I framework ### Class I: lowest risk, self-assessment pathway Class I medical devices are the lowest risk class under Australia's medical device regulatory framework. They do not contact internal body tissues, are non-sterile, and do not have a measuring function. Class I devices follow a self-assessment pathway — there is no mandatory third-party conformity assessment by a TGA-recognised body, but the manufacturer must still comply with the Essential Principles and include the device on the Australian Register of Therapeutic Goods (ARTG) before supply. ### Essential Principles compliance All medical devices — including Class I — must comply with the Essential Principles of safety and performance set out in Schedule 1 to the Therapeutic Goods (Medical Devices) Regulations 2002. Compliance is typically demonstrated by conformity with applicable standards (ISO 13485 for quality management, and product-specific standards such as IEC 60601 series for electrical medical devices, or ISO 14971 for risk management). Compliance documentation is held by the manufacturer and must be available on request. ### Sponsor obligations In Australia, devices are included on the ARTG by the sponsor — an Australian entity (or foreign entity with an Australian presence) responsible for the device's supply in Australia. The sponsor holds the ARTG entry, accepts regulatory obligations including post-market monitoring and adverse event reporting, and must have a written agreement with the manufacturer confirming access to technical documentation. ### Class I sterile and Class I measuring function Class I devices that are supplied sterile (Class Is) or that have a measuring function (Class Im) are subject to additional requirements: the sterility aspects of Is devices require third-party conformity assessment, and Im devices require assessment of their measuring function. These sub-classes have higher conformity assessment requirements than standard Class I and should not be confused with the base Class I self-assessment pathway. ## ARTG inclusion process 01 Classify the device using the classification rules in Schedule 2 to the Therapeutic Goods (Medical Devices) Regulations 2002 — confirm it meets Class I criteria (non-sterile, non-measuring, not contacting internal tissues) and is not reclassified to a higher class by a specific rule. 02 Compile the technical documentation demonstrating compliance with the Essential Principles — this includes the device description, design and manufacturing information, risk management file (per ISO 14971), clinical evidence, and performance test data. 03 Confirm the quality management system (QMS) for Class I manufacturing — while third-party QMS certification (ISO 13485) is not mandatory for base Class I, the manufacturer must have a QMS in place; international manufacturers who also sell to the EU or US are typically already ISO 13485 certified. 04 Engage an Australian sponsor or ensure the foreign manufacturer has an Australian legal presence capable of holding an ARTG entry. 05 Apply for ARTG inclusion via the TGA's Business Services portal — submit the device description, classification justification, Essential Principles compliance summary, and sponsor declaration. 06 Pay the applicable ARTG inclusion fee and annual charge — the TGA's fee schedule applies per device group; Class I fees are lower than higher-class devices but are still required annually to maintain ARTG status. 07 Once included on the ARTG, maintain post-market obligations: report adverse events to the TGA within the required timeframes, maintain technical documentation, and keep the sponsor record current if Australian business details change. ## Frequently asked questions ### What makes a device a medical device in Australia? A medical device is defined in the Therapeutic Goods Act 1989 by its intended purpose: it must be intended by the manufacturer to be used in or on human beings for diagnosis, prevention, monitoring, treatment, or alleviation of a disease, injury, or disability; or for investigation, replacement, or modification of anatomy or a physiological process; or for control of conception. Intended purpose is determined by the manufacturer's claims, labelling, and instructions — not just the product's technical capability. ### Can a general wellness product be regulated as a medical device? General wellness products that make no medical claims and are not intended to diagnose, treat, or prevent disease are typically not medical devices. However, if the product's labelling, marketing, or app interface makes health or medical claims — even implicitly — the TGA may consider it a medical device and require ARTG inclusion. The line between a wellness product and a medical device is fact-specific and the TGA's guidance should be reviewed carefully before marketing a health-adjacent product in Australia. ### How does Australian Class I compare to EU MDR Class I? Australia's Class I is broadly aligned with EU MDR Class I in scope — both cover low-risk, non-sterile, non-measuring devices that are not implantable. The compliance pathways differ: EU MDR Class I requires an EC Declaration of Conformity and CE marking, while Australian Class I requires ARTG inclusion by a sponsor. Technical documentation requirements are similar, and EU-compliant Class I devices typically need only incremental work to achieve Australian compliance, primarily the ARTG application and sponsor arrangements. ### What are the penalties for supplying an unregistered medical device? Supplying a medical device that is not included on the ARTG is a criminal offence under the Therapeutic Goods Act 1989. Penalties include substantial fines (thousands of penalty units) and imprisonment. The TGA also has civil penalty provisions and can issue infringement notices. Importantly, the sponsor — the Australian entity holding the ARTG entry — bears primary regulatory responsibility, so the choice of sponsor and the sponsor agreement are critical risk management decisions. **Disclaimer:** Educational resource only. Medical device classification and regulatory requirements are product- and intended-purpose-specific. Consult a qualified Australian regulatory affairs consultant or TGA-accredited body before making ARTG submission decisions. 🇦🇺 Australia roadmap for your product Every standard, document, and test that applies — free, no account required. See your free roadmap[ Want an expert to take your product through 🇦🇺 Australia compliance for you? One consultant from Krono's compliance team takes your product from requirements to legal sale, with a fixed quote before any work starts. 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