FDAnews Device Daily Bulletin
Medical Devices / Regulatory Affairs

TGA and Philips Sign MOU Over Defibrillator Supply

Dec. 26, 2018
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Australia’s Therapeutic Goods Administration and Philips Electronics have entered into a memorandum of understanding under which Philips has agreed to notify the agency of any anticipated shortage of parts associated with its HeartStart MRx defibrillator and to provide service as needed.

Philips advised the TGA in May 2017 that the HeartStart MRx would no longer be supplied, but it continues to be used and supported in hospitals, clinics and ambulances across Australia.

Under the agreement, Philips has agreed to continue service until Dec 31, 2022, and it will meet with the TGA twice yearly and report adverse events as required under normal operations.

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