2025-2026 Regulatory Updates: CAP Revision Consultation, UDI Transition Pathway and Guideline Updates

1. Key takeaways

Over the past two years Australia has seen four regulatory variables moving in parallel: the conformity assessment procedures (CAP) revision consultation, the UDI transition channel, updates to the clinical evidence guidelines, and an expansion of the software regulatory guidance. Among these, the CAP consultation ran from 18 December 2025 to 14 April 2026 and comprised 8 proposals; the TGA stated explicitly that it does not change the way approvals and assessments by overseas regulators are recognised. That commitment is the single most consequential fact in the consultation for any sponsor relying on an overseas pathway, and it frames how the remaining proposals should be read.

2. Legal basis

The four variables each have their own official documents and dates, summarised below as they stand at the time of verification.

1. CAP revision consultation: TGA, Public consultation for proposed changes to medical device conformity assessment procedures, consultation period 18 December 2025 — 14 April 2026 (originally to 27 February 2026, extended in response to industry feedback); proposals 1–5 mainly concern the TGA conformity assessment certification route, while proposals 6, 7 and 8 also apply to devices certified by trusted overseas regulators; the stated aims are clearer and more consistent requirements, alignment with international practice to reduce unnecessary burden, timely access for innovative devices, strengthened quality management and design control (including software and emerging technologies), and earlier identification of safety and performance issues; the way approvals and assessments by overseas regulators are recognised does not change.
2. UDI transition channel consultation: TGA UDI consent to supply consultation, opened 10 December 2025, closed 23 January 2026; it was designed to give sponsors who cannot meet UDI requirements by the compliance date a simplified application process and reduced fees; it allows a 2-year period of non-compliance that cannot be extended.
3. Clinical evidence guidelines update: TGA, Clinical evidence guidelines for medical devices, most recently updated 11 September 2026, with a new chapter on computational modelling and simulation; updated in the same period were Demonstrating evidence to comply with the Essential Principles and Real World Evidence (both 11 September 2026).
4. Expansion of software regulatory guidance: on 16 March 2026 the TGA published a software exclusion overview page together with item-by-item guidance covering 15 exclusion categories (under Schedule 1 of the Therapeutic Goods (Excluded Goods) Determination 2018); multi-function software must satisfy the exclusion criteria for every function.
5. Clinical decision support system (CDSS) guidance: TGA, Understanding clinical decision support system software regulation; the regulation page’s list of guidance referencing the law is dated 16 October 2026; a three-step method (is it a medical device → does it support clinical decisions → does it meet all three exemption criteria); the exemption criteria appear in Schedule 4, Part 2 of the Therapeutic Goods (Medical Devices) Regulations 2002 (a — the software only provides or supports advice to health professionals; b — it does not directly process or analyse images or signals from other medical devices or IVDs; c — it does not replace clinical judgment; it must be transparent and verifiable, and a black box is not exempt); even exempt devices must notify the TGA within 30 working days of supply, comply with the Essential Principles, report adverse events, and comply with advertising requirements.
6. Strategic document: TGA, Medical devices reforms: An Action Plan for Medical Devices, published 4 April 2019; its three strategic directions are improving market access pathways for new devices, strengthening monitoring and follow-up of devices in use (including initiating UDI, enhanced inspection and review, exploring mandatory hospital adverse event reporting, and stronger data analytics and hospital system integration), and providing more information to patients.

3. Expert insights

Insight 1: the CAP consultation’s commitment not to change overseas recognition is a stability anchor. Of the 8 proposals, the TGA stated explicitly that the way approvals and assessments by overseas regulators are recognised will not change. For companies relying on the COR route, this means the existing evidence strategy will not be overturned in the short term.

Insight 2: the CDSS exemption requires all three criteria to be met, and a black box is not exempt. The three criteria — advice provided only to health professionals, no direct processing or analysis of images or signals from other devices, and no replacement of clinical judgment — must be satisfied simultaneously, and the software must be transparent and verifiable. An AI product that cannot explain its decision logic cannot take the exemption route.

Insight 3: the software exclusion guidance was published as more than a dozen item-by-item documents in one release. The 16 March 2026 package turns exclusion from a principle into an operational, category-by-category determination. The first step for a software company should be to screen function by function, rather than to assume first that the product is a device.

4. Practical recommendations

• Track the follow-up legislative instruments from the CAP consultation, and complete an internal comparison within 30 days of the official text being published, focusing on the final form of proposals 6, 7 and 8.
• Self-check AI and CDSS products against the three exemption criteria, and plan products that cannot explain their decision logic along the full device pathway.
• Screen software products function by function against the 15 exclusion categories published on 16 March 2026, and keep the determination records and dates.
• Cite the clinical evidence guidelines as the 11 September 2026 version, and assess whether the computational modelling and simulation route applies.

5. Verification checklist

• □ Follow-up legislative instruments from the CAP consultation are being tracked, with a 30-day comparison mechanism in place
• □ The impact of proposals 6, 7 and 8 on the company’s products has been confirmed
• □ AI and CDSS products have been self-checked against the three exemption criteria
• □ Software products have been screened function by function against the 15 exclusion categories
• □ Clinical evidence citations refer to the 11 September 2026 version

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 adverse event reporting and recall coordination with the TGA, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com