ARTG-listed ECMO devices in Australia: what to know before you buy

In Australia, all medical devices used in clinical practice — including ECMO systems — must be listed on the Australian Register of Therapeutic Goods (ARTG) administered by the Therapeutic Goods Administration (TGA). Procuring an ECMO system without verifying ARTG listing exposes hospitals to significant regulatory and legal risk, and may affect indemnity coverage for clinical events involving the device. This article explains the ARTG framework and what procurement teams need to know.

What is the ARTG?

The ARTG is Australia's register of therapeutic goods — medicines, biologicals and medical devices — that are approved for legal supply in Australia. Class III medical devices (which include ECMO systems, oxygenators and centrifugal pumps) require the highest level of TGA scrutiny before listing. The TGA evaluates safety, performance and quality evidence, relying substantially on international regulatory approvals (CE Mark under EU MDR, FDA clearance or approval) as part of the assessment process.

Why ARTG listing matters for procurement

• Legal requirement: supplying or using a non-ARTG-listed Class III device in Australia is prohibited under the Therapeutic Goods Act 1989
• Indemnity: clinical events involving unlisted devices may not be covered by hospital indemnity insurance
• Biomedical engineering: hospital biomedical departments are required to verify TGA registration for all devices entering clinical use
• Tender compliance: government hospital procurement processes explicitly require ARTG listing for Class III devices

How to verify ARTG listing

The TGA's public ARTG search tool (available at tga.gov.au) allows anyone to search for registered devices by sponsor name, device type, or ARTG number. Each listing includes the device name, sponsor, ARTG number, and listing status (active/cancelled). Procurement teams should verify listing for each individual component — console, oxygenator, pump head, cannulae — as each may have a separate ARTG entry.

The Lifemotion ECMO system and ARTG

The Lifemotion ECMO system — distributed exclusively across Australia and New Zealand by OHM Healthcare — holds multiple ARTG listings covering the console, centrifugal pump head, membrane oxygenator and ECMO sets. Verification of current listing status can be performed via the TGA ARTG search tool or by contacting OHM Healthcare directly.

CE Mark (MDR) and its relevance to ANZ

CE marking under the European Union Medical Device Regulation (MDR 2017/745) is the most stringent international regulatory standard for medical devices and is recognised by the TGA as a primary evidence source for Australian ARTG listing. The Lifemotion ECMO system holds CE Mark (MDR) certification. New Zealand uses the ARTG as a primary reference through the joint ANZTPA framework, or independent Medsafe review.

To verify ARTG listings and discuss ECMO system procurement for your institution — contact us.

lifemotionecmo.com.au  |  ohmhealthcare.com.au

For hospital procurement teams and biomedical engineers. Educational only — verify current ARTG listing via tga.gov.au before procurement decisions.