Australia Special Access and Clinical Trials for Unapproved Devices

1. Key takeaways

Devices not included in the ARTG still have two lawful entry points in Australia: clinical trials (exemptions under the CTN / CTA schemes) and special access (the SAS and Authorised Prescribers). The two entry points draw on different provisions — the former sits in the exemption schedules of the Therapeutic Goods (Medical Devices) Regulations 2002, the latter in the authorised use provisions of the Therapeutic Goods Act 1989. Neither route suspends the ordinary enforcement provisions, so the conditions attached to each are not optional. Facts verified as of 29 October 2026.

• Clinical trial device exemptions and conditions: Schedule 4 Part 2 item 2.3; powers of authorised persons over trial devices: regulation 7.4.
• Special access provisions in the Act: section 41HB (approved use) and section 41HC (categories of medical practitioners and recipients).
• SAS applications are made case by case by a registered Australian health practitioner for a single patient.
• An Authorised Prescriber supplies a specified unapproved good to a class of patients, requires HREC approval or professional body endorsement, and must receive the TGA approval letter before supplying.
• The Personal Import Scheme also exists as a separate channel, outside both of the routes above.

2. Legal basis

The two routes are anchored in different instruments, and each carries its own conditions and notification duties that must be read together with the operation of the schemes. Because the routes live in different instruments, the obligations should be tracked in two separate lists rather than one combined register.

• Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237, compilation F2026C00883): the exemption and conditions for devices for use in clinical trials are in Schedule 4 Part 2 item 2.3; the powers of authorised persons over devices in clinical trials are in regulation 7.4.
• Special access and authorised prescribers (Therapeutic Goods Act 1989, Act No. 21, 1990): section 41HB (approved use); section 41HC (categories of medical practitioners and categories of recipients).
• Supporting regulation provisions: regulation 7.2 (exempt goods in life-threatening situations); regulations 7.3 / 7.5 (conditions on use by persons authorised); regulation 7.6 (categories of medical practitioners and recipients); regulation 7.7 (circumstances of supply); regulation 7.8 (information that must be notified).
• Clinical trial scheme names: the Clinical Trial Notification (CTN) scheme and the Clinical Trial Approval (CTA) scheme are the lawful import and supply pathways for unapproved therapeutic goods in human trials; the trial sponsor decides between CTN and CTA (TGA “Australian clinical trial handbook”).
• Institutional description: under the SAS, a registered Australian health practitioner applies case by case for a single patient; the Authorised Prescriber (AP) route allows an authorised doctor to supply a specified unapproved good to a class of patients with a particular condition, and requires HREC approval or professional body endorsement, with supply permitted only after the TGA approval letter has been received.
• A separate Personal Import Scheme also exists.

3. Expert insights

Insight 1: the clinical trial exemption is conditional, not unregulated. Item 2.3 sits in Schedule 4 Part 2 (conditional exemptions), and regulation 7.4 separately confers powers on authorised persons over devices used in trials. Both provisions should be read together at the protocol design stage, because the conditions they impose shape what the protocol can and cannot do operationally in Australian sites. The conditions should be translated into the trial’s standard operating procedures before the first patient is enrolled.

Insight 2: the SAS and the AP differ in granularity. The SAS addresses a single patient, application by application; the AP covers a class of patients supplied under the authorised doctor. Products in early clinical validation belong in the SAS; where a stable user population already exists and scaled supply is the goal, the AP route fits better. Choosing the wrong granularity wastes either preparation effort or patient access time. Moving from the SAS to the AP route later does not restart clinical development, but it does require the endorsement and approval sequence to be completed. A portfolio review usually shows that different products sit at different granularities, and the access strategy can be staged accordingly.

Insight 3: the AP preconditions are HREC approval or professional body endorsement, plus the TGA approval letter. The sequence cannot be reversed — supplying before the approval letter arrives is, in character, the supply of a device not included in the ARTG (see article 35 of this series for the penalty provisions). The approval letter is a gating document, not a formality, and contracts with prescribers should reflect that sequence explicitly. Building the approval letter into the supply contract as a condition precedent makes the sequence self-enforcing at the commercial level.

4. Practical recommendations

• For clinical trial projects, check the item 2.3 exemption conditions and the regulation 7.4 authorised person powers together, and break the conditions into a protocol execution checklist, with each condition assigned to a named owner in the trial team.
• When deciding between CTN and CTA, base the call on trial risk and product status, record the rationale in the protocol, and revisit the choice if the risk profile changes during the trial.
• For SAS projects, keep a file per single patient and retain application and approval records; for AP projects, complete the HREC or professional body endorsement first, then await the TGA approval letter, and supply only after approval, with the approval letter check diarised before any supply date.
• Submit the notifiable information required by regulation 7.8 on time, so the exemption conditions do not lapse for want of notification.

5. Verification checklist

• □ Clinical trial projects have been checked against the item 2.3 exemption conditions and regulation 7.4
• □ The rationale for choosing CTN or CTA has been recorded
• □ SAS projects have per-patient files and retained approval records
• □ AP projects have completed HREC or professional body endorsement and received the TGA approval letter
• □ Regulation 7.8 notifiable information has been submitted on time

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 ARTG inclusion across all classes, prepares conformity assessment dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanlang.com