For hospital procurement teams, clinical governance committees, and biomedical departments evaluating an ECMO platform, regulatory status is not a footnote. It is the first question.
The Lifemotion ECMO system is registered on the Australian Register of Therapeutic Goods. OHM Healthcare is the sponsor.
ARTG registrations
The platform holds four current ARTG entries, covering each major component:
Console: ARTG 528964
Oxygenator: ARTG 528771
Pump head: ARTG 528772
Circuit sets: ARTG 528773
ARTG registration confirms that the TGA has reviewed the available information for each device and formed the view that it meets the requirements of the Therapeutic Goods Act 1989. It is not a clinical endorsement or an approval of any specific use — the ARTG is a register, and registration is a regulatory baseline, not a performance guarantee.
New Zealand
Supply of the Lifemotion ECMO system in New Zealand is subject to New Zealand regulatory requirements. OHM Healthcare is the exclusive ANZ distributor. For New Zealand-specific regulatory enquiries, contact OHM Healthcare directly.
CE Mark under EU MDR
The Lifemotion ECMO system holds CE Mark under the European Medical Device Regulation (EU MDR). EU MDR is considered one of the more stringent global regulatory frameworks for medical devices, and its requirements extend to clinical evaluation, post-market surveillance, and device traceability.
OHM Healthcare as sponsor
As ARTG sponsor, OHM Healthcare carries the regulatory obligations that come with that designation under Australian law. This includes obligations regarding device supply, adverse event reporting, and compliance with TGA requirements. It is not a passive role.
For procurement teams assessing a new ECMO platform, knowing the local distributor is also the ARTG sponsor — with an ISO 9001:2015 quality management system and AS/NZS 3551-compliant service infrastructure — matters for the lifecycle question, not just the initial acquisition.
For clinical and procurement enquiries
Contact OHM Healthcare for regulatory documentation, procurement information, or to arrange a demonstration or wet-lab session.
sales@ohmhealthcare.com.au · 03 9115 7464 · lifemotionecmo.com.au
For healthcare professionals and healthcare organisations. Product availability and specifications subject to the locally approved Instructions for Use.
OHM Healthcare · sales@ohmhealthcare.com.au · 03 9115 7464
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