Regulatory status of the Lifemotion ECMO system

For a hospital procuring an ECMO platform, regulatory status is not a formality — it is the foundation of the purchasing decision. The Lifemotion ECMO system holds four current entries on the Australian Register of Therapeutic Goods (ARTG), covering each core component of the circuit.

ARTG entries (Australia)

Inclusion on the ARTG means each product has been entered on the Therapeutic Goods Administration (TGA) register for supply in Australia. Always confirm the current entry details and approved indications against the ARTG and the product's instructions for use (IFU).

CE Mark (MDR)

The Lifemotion ECMO system also holds CE Mark certification under the European Medical Device Regulation (MDR) — one of the more demanding regulatory frameworks internationally — reflecting the platform's broader certification pathway.

Quality behind the local supply

The system is distributed and supported in Australia and New Zealand by OHM Healthcare, an ISO 9001:2015-certified biomedical distributor and service provider. That quality system underpins installation, commissioning, documentation and ongoing service.

Service, maintenance and compliance

Beyond initial supply, ECMO equipment sits within a hospital's biomedical maintenance and compliance obligations (including Australian standards for the management of medical electrical equipment). OHM Healthcare's clinical engineering team supports scheduled service and maintenance so a service can keep its ECMO capability audit-ready.

New Zealand — WAND

The Lifemotion ECMO system is included in the New Zealand WAND (Web Assisted Notification of Devices) register. WAND is Medsafe’s notification database for medical devices supplied in New Zealand. Always confirm current WAND registration details and approved indications against the WAND database and the product’s current IFU.

Talk to us about your regulatory or procurement questions →

For healthcare professionals. ARTG entries, certifications and specifications are subject to change and to the locally approved instructions for use (IFU). Confirm current details with OHM Healthcare and the relevant registers.