Australia Comparable Overseas Regulators: Recognised Evidence for TGA Applications

1. Key takeaways

Australia has turned “substituting domestic review with overseas review outcomes” into a statutory list: comparable overseas regulators (COR) are listed in regulations 5(a)–(i) of the Therapeutic Goods (Overseas Regulators) Determination 2018. The current compilation, version 3, took effect on 1 December 2025 and covers 9 categories of bodies, with the latest version adding the UK approved body. Because the list is periodically expanded, evidence planning should always be checked against the compilation version in force at the time of filing. Facts verified as of 29 October 2026.

• Legal source: section 41BIB(2) of the Therapeutic Goods Act 1989; the determination was made on 11 September 2018.
• Current list (regulation 5(a)–(i), version of 1 December 2025): nine categories, from IAF-accredited conformity assessment bodies to the US FDA and UK approved bodies.
• Japan appears twice — MHLW and PMDA are both listed — because the list is one of body types, not countries.
• Designation criteria comprise five limbs: comparable regulatory framework, IMDRF membership, full lifecycle and post-market vigilance, communication and cooperation with overseas regulators, and professional competence.
• The 2024 amendment F2024L01328 lets FDA 510(k)-exempt Class IIa devices rely on a single MDSAP certificate for ARTG inclusion — the leanest evidence combination in the current framework.

2. Legal basis

The recognition framework rests on a determination made under the Act, progressively expanded through amendment instruments, plus a targeted easing of information requirements for a narrow Class IIa scenario. The list also interacts with the Information Determination, which sets what documents must accompany each kind of application, and each amendment instrument is cited by registration number so the timeline can be reconstructed from the Federal Register of Legislation.

• Therapeutic Goods (Overseas Regulators) Determination 2018, registration number F2018N00145; made under section 41BIB(2) of the Therapeutic Goods Act 1989; as made, it commenced on 11 September 2018; current compilation version 3 (F2025C01149), effective 1 December 2025.
• Current designated list (regulation 5(a)–(i), version of 1 December 2025): (a) IAF-accredited conformity assessment bodies (ISO 13485 certification); (b) European Union notified bodies; (c) MDSAP recognised or authorised auditing organisations; (d) Health Canada; (e) Singapore HSA; (f) Japan MHLW; (g) Japan PMDA; (h) United States FDA; (i) UK approved body.
• Designation history: the original version of 11 September 2018 (EU notified bodies, MDSAP auditing organisations, Health Canada, MHLW, PMDA, FDA); F2019N00039 (10 April 2019); F2022N00198 (9 September 2022, adding Singapore HSA); F2025N00863 (registered 30 October 2025) added the UK approved body.
• Designation criteria (five): comparability of the regulatory framework; IMDRF membership; full lifecycle and post-market vigilance; communication and cooperation with overseas regulators; and professional competence of the body.
• 2024 expansion route: Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment (No. 2) Determination 2024 (F2024L01328, registered 18 October 2024), amending Schedule 1 Part 2 — for Class IIa devices already exempted by the US FDA from the 510(k) requirements, an application for ARTG inclusion needs only one MDSAP certificate to accompany it.

3. Expert insights

Insight 1: the list is one of body types, not of countries. Regulation 5 lists bodies — notified bodies, auditing organisations, regulators — not countries. A single country can host several designated bodies at once (Japan appears through both MHLW and PMDA), which means the issuing entity of every piece of evidence must be checked, not merely the flag on the certificate. A document issued by the wrong type of body fails even if the country is right. The same discipline applies to ISO 13485 certificates, since item (a) turns on IAF accreditation of the body, not on the certificate alone.

Insight 2: the significance of the 1 December 2025 version is that the UK route has landed. The addition of the UK approved body, together with the concepts of “applied Directive 93/42” and “applied Directive 98/79” introduced in parallel through the Information Determination (meaning the UK-transposed versions of those directives), means that post-Brexit UK certification is recognised by Australia on its own terms. It can no longer be swept under a generic “EU certificate” label (see article 16 of this series). Sponsors holding both EU and UK certificates should keep the two evidence sets as distinct lines in the dossier rather than merging them.

Insight 3: F2024L01328 is an under-appreciated shortcut. For Class IIa devices already exempted from 510(k) requirements by the FDA, a single MDSAP certificate satisfies the accompanying information requirement. Products of this kind are often assumed to be “evidence-poor”, yet in practice they enjoy the leanest combination available on the Australian menu — if the route is identified early enough in planning. The route also depends on the FDA decision being current, so the exemption letter should be checked for scope against the exact device being filed.

4. Practical recommendations

• Maintain an inventory of existing overseas evidence and check each item against regulation 5(a)–(i) by issuing body, not by country.
• Handle UK certificate projects separately: confirm the issuer is a UK approved body and that the certificate maps to the UK-transposed version of the directive.
• For Class IIa products holding an FDA 510(k) exemption decision, evaluate the F2024L01328 route first to avoid duplicating product evaluation evidence.
• Re-verify the COR determination compilation annually (currently version 3, effective 1 December 2025); the list is likely to keep growing, and any new body type should be noted in the evidence ledger.

5. Verification checklist

• □ The issuing body of each piece of overseas evidence has been checked against regulation 5(a)–(i)
• □ The current version of the COR determination has been confirmed as version 3 (1 December 2025)
• □ UK certificate projects have been checked separately for approved body status and directive version
• □ Class IIa products with FDA 510(k) exemptions have been assessed for the single MDSAP certificate route
• □ An annual review point for the COR list has been scheduled

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