Exemptions and Exclusions from ARTG Inclusion in Australia

1. Key takeaways

Australia provides two channels that avoid inclusion in the ARTG, and their legal consequences are entirely different. Under exemption, pursuant to regulation 7.1 and Schedule 4 of the Therapeutic Goods (Medical Devices) Regulations 2002, the exempted product remains a medical device and may still carry advertising, adverse event reporting, and notification obligations. Under exclusion, pursuant to a Declaration under section 41BD(3) of the Therapeutic Goods Act 1989, the excluded article is not a medical device at all. Choosing between the channels is therefore not a semantic exercise; it determines which residual duties survive, which records must be kept, and what happens when a product is challenged. A sponsor who documents the channel, the specific item relied upon, and the surviving obligations at the time of the decision holds a defensible position; a sponsor who merely asserts that the product is not registered leaves every downstream question open.

2. Legal basis

1. Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237, compilation F2026C00883): the legal basis for exemption is regulation 7.1 and Schedule 4 (authorised by section 41HA of the Therapeutic Goods Act 1989).
2. Schedule 4 Part 1 (unconditional exemptions), items 1.1–1.7: devices imported for personal use by the importer or immediate relatives in limited quantity; non-commercial export; samples; oxygen head hoods for hyperbaric oxygen chambers; articles assembled by health professionals from devices already included in the Register; import for re-export under customs supervision throughout; spectacle lenses dispensed against an optometry prescription; and item 1.7 patient-matched devices.
3. Schedule 4 Part 2 (conditional exemptions), items 2.1–2.20 (selected): item 2.3 devices for use in clinical trials; item 2.10 in-house IVDs (Class 1–3); items 2.12 (manufactured in Australia) and 2.13 (manufactured outside Australia) custom-made devices; item 2.14 patient-matched devices; item 2.15 clinical decision support (CDSS) software; item 2.19 certain Class 4 in-house IVDs; item 2.20 devices for Department of Defence use.
4. Key definitions (regulation 1.3): a custom-made device is made for a specific patient or for the exclusive use of a specific health professional, manufactured in accordance with specific design characteristics stated in a written request of that health professional (the design may be developed in consultation with the manufacturer); a patient-matched device is manufactured to match the anatomy, physiology, or pathology of a specific individual within a stated design envelope, designed by the manufacturer (in consultation with a health professional), and produced using a verifiable and validated manufacturing process.
5. Exclusion channel: section 41BD(3) of the Therapeutic Goods Act 1989; current instrument, the Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023 (F2023L01088, compilation C03, effective 1 January 2026), with 16 items in Schedule 1.
6. Clinical trial-related power: regulation 7.4 (powers of authorised persons over devices in clinical trials).

3. Expert insights

Insight 1: Exemption is a conditional status, not an inspection-free pass. Every item in Schedule 4 Part 2 carries conditions; for example, custom-made devices must follow the procedure in Schedule 3 Part 7, and custom-made devices manufactured outside Australia require device information to be provided to the Secretary within 2 months of first importation. Reading exemption as zero obligation causes failures precisely at the notification and reporting steps, which are the steps most easily evidenced by the regulator. The disciplined approach is to treat the exemption item as a mini-regulation in itself: enumerate its conditions, assign each to an owner, and calendar every deadline it contains.

Insight 2: The dividing line between custom-made and patient-matched is design authorship. A custom-made device is driven by design characteristics stated in the written request of the health professional; a patient-matched device is designed by the manufacturer within a stated design envelope. Products emerging from 3D printing sit easily between the two, and a wrong determination affects both the validity of the exemption and ARTG obligations (see article 18 for details). The evidence that settles the question is documentary: the written request, the design envelope specification, and the process validation records, all of which should exist before the product is supplied rather than being assembled after a query arrives.

Insight 3: CDSS software travels through exemption, not exclusion. Item 2.15 exempts qualifying CDSS software from inclusion in the ARTG, but it remains a medical device, and advertising, adverse event reporting, and post-supply notification obligations may remain. This is a different mechanism from the software exclusion lists, and the two must not be conflated (see article 10 for details). The distinction matters commercially as well as legally, because an exempted device still operates inside the device perimeter and its marketing claims, complaint handling, and recall readiness all remain within scope of the device obligations.

4. Practical recommendations

1. When issuing an ARTG obligation determination, state expressly whether the product travels the exemption channel or the exclusion channel, and attach a list of the residual obligations that survive the choice.
2. For items under Schedule 4 Part 2, decompose the conditions into executable actions (notification deadlines, record retention, reporting duties) and assign each to a named owner, so that the exemption is administered rather than merely claimed.
3. For 3D-printed and personalised products, classify first against the two definitions in regulation 1.3, and only then select the procedure and the exemption item, because the classification drives everything downstream.
4. For projects involving clinical trials and special access, check regulation 7.4 and regulations 7.2–7.8 in the same review (see article 20 for details), since the trial powers and the exemption items interact at the boundary of supply.

5. Verification checklist

• □ The two channels, exemption (Schedule 4) and exclusion (F2023L01088), have been expressly distinguished
• □ All condition clauses and residual obligations of the applicable exemption item have been listed
• □ Custom-made and patient-matched devices have been correctly classified under the regulation 1.3 definitions
• □ For custom-made devices manufactured outside Australia, a notification checkpoint is set at 2 months after first importation
• □ CDSS software has been confirmed to travel the exemption channel rather than exclusion, with notification obligations retained

Regulatory information verified as of 29 October 2026.

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Australian market. Our team manages TGA inclusion and ARTG listing applications, coordinates conformity assessment evidence, and supports post-market vigilance obligations. Business enquiries: info@grzan.cn