ARTG Entry Variation Management for Medical Devices and IVDs

1. Key takeaways

The red line for changes to ARTG entries is that the kind of device must not change. The elements for determining the same kind appear in section 41BE(1) of the Therapeutic Goods Act 1989; for Class III devices, AIMDs, Class 4 IVDs (other than immunohaematology reagents) and IVD companion diagnostics, regulation 1.6 adds the unique product identifier (UPI) as an element of kind — for these classes there is in effect one entry per model. Every proposed change should therefore be tested against the kind elements before any form is selected, because the answer determines whether the variation channel is open at all.

• The variation entry point is section 9D(1) of the Act.
• Section 41BE(1)(a)–(e): the same sponsor, the same manufacturer, the same GMDN code and the same classification, together with other characteristics prescribed by the regulations.
• Regulation 1.6 makes the UPI the additional characteristic for Class III devices, AIMDs, Class 4 IVDs (other than immunohaematology reagents) and IVD companion diagnostics.
• Notification-only situations include clause 5.12 (20 working days notice before import, supply or export for certain devices), Schedule 3 Part 1 clause 1.5 (substantial changes to the quality management system or its scope of application), clause 1.6(4) (substantial changes to design or intended performance) and section 41EJ (changes affecting a TGA conformity assessment certificate).
• Sponsor changes follow sections 10F and 10FA of the Therapeutic Goods Regulations 1990.
• Form selection follows the TGA user guide (1 December 2025): Class III/AIMD Variation, IVD Variation or Device Change Request (DCR), and no statutory timeframe applies to variation assessment.
• Implementing a change before approval constitutes a breach of the conditions of inclusion.

2. Legal basis

Therapeutic Goods Act 1989 (Act No. 21, 1990): the variation entry point is section 9D(1); the same-kind determination appears in section 41BE(1)(a)–(e) — the same sponsor, the same manufacturer, the same GMDN code and the same classification, together with other characteristics prescribed by the regulations.

Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237, compilation F2026C00883): regulation 1.6 — for Class III devices, AIMDs, Class 4 IVDs (other than immunohaematology reagents) and IVD companion diagnostics, the “other characteristics” are the unique product identifier (UPI).

Situations requiring notification only: regulation 5.12 — 20 working days notice before intended import, supply or export for certain devices (including Class 3 and Class 4 IVDs, in-house IVDs, self-testing and point-of-care testing IVDs, and spinal fusion implants); Schedule 3 Part 1 clause 1.5 — substantial changes to the quality management system or its scope of application require written notice and arrangement for assessment; clause 1.6(4) — substantial changes to design or intended performance; and section 41EJ of the Therapeutic Goods Act 1989 — changes affecting a TGA conformity assessment certificate must be notified.

Sponsor changes: sections 10F (change of sponsor) and 10FA (change of device name) of the Therapeutic Goods Regulations 1990.

Form allocation (TGA user guide Varying your medical device or IVD ARTG entry, dated 1 December 2025): variations to the UPI, the device total, the function description and the product variant list for Class III or AIMD go to the Class III/AIMD Variation form; adding same-kind IVDs goes to the IVD Variation form; everything else goes to the Device Change Request (DCR) form; no statutory timeframe applies to variation assessment.

Consequences: a variation that causes the device to cease to be the same kind will not be accepted, and a new inclusion application must be submitted; implementing a change without approval constitutes a breach of the conditions of inclusion. Both consequences arise from the same logic: the ARTG entry is defined by the kind, so a change that breaks the kind cannot ride on the existing entry.

3. Expert insights

Insight 1: the UPI is the kind boundary for the high-risk classes. Regulation 1.6 makes the UPI an element of kind for Class III devices, AIMDs, Class 4 IVDs other than immunohaematology reagents, and companion diagnostics. Model changes for these products cannot proceed through the variation channel and require a fresh application — which means a new application fee and a new probability of audit.

Insight 2: low and medium-risk products can hold one entry with multiple models. The first limb of section 41BE(1) requires only the same sponsor, the same manufacturer, the same GMDN code and the same classification. Low and medium-risk products may consolidate models where these four conditions are met (see article 40 for the cost modelling).

Insight 3: implementing a change before approval is itself a breach. Implementing a variation before it is approved constitutes a breach of the conditions of inclusion. Many companies treat the change as an internal engineering decision and switch production while the application is still being submitted; in Australia this is an independent risk point.

4. Practical recommendations

• Before any change, run a kind determination: list the five elements of section 41BE(1) and check each one, with an additional check of the UPI for the high-risk classes.
• Select the form by change content: changes to the UPI, the device total, the function description or the variant list go to the Class III/AIMD Variation form; adding same-kind IVDs goes to the IVD Variation form; the rest goes to the DCR.
• Substantial changes on the quality system and design sides simultaneously trigger the notification obligations of Schedule 3 Part 1 clauses 1.5 and 1.6(4); do not overlook them.
• For devices covered by clause 5.12, build the 20-working-day notice period into the import and supply schedules.

5. Verification checklist

• □ A kind determination has been made against the five elements of section 41BE(1)
• □ The UPI element of regulation 1.6 has been checked for the high-risk classes
• □ The correct form has been selected for the change content
• □ Substantial system and design changes have triggered the clause 1.5 and 1.6(4) notifications
• □ The 20-working-day notice period of clause 5.12 has been reserved for specific devices
• □ No change has been implemented before approval

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 prepares TGA-compliant CTOs and evidence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com