Community Health Reform

GOVERNMENT ACKNOWLEDGES STRENGTH OF AUSTRALIA’S DEVICE REGULATIONS

This week TGA released An Action Plan for Medical Devices, acknowledging that:

“The regulatory requirements for medical devices in Australia are some of the most stringent in the world. Compliance by industry with these requirements is never optional or voluntary. The obligations are based on globally aligned requirements that regulate different products according to their risk.”

The medical devices industry welcomed this acknowledgement by the Federal Government that the regulatory requirements for medical devices in Australia are highly rigorous.

Patients benefit most when they have timely access to innovative new technologies and Government’s recognition of this as they work to strike right balance with effective and appropriate scrutiny of these technologies is crucial.

The medical devices industry supports measures proposed in the Action Plan to improve adverse event reporting by healthcare professionals and hospitals and welcomes moves to strengthen community awareness of how the safety and performance of medical devices is assessed.

Medical Technology Association of Australia’s CEO, Ian Burgess, said the MedTech industry welcomed the Government’s ongoing recognition of Australia’s regulatory requirements for medical devices as being amongst the most rigorous in the world.

“We are also pleased that Government has acknowledged that this rigor must be balanced with the need for patients to be able to access to new breakthrough technologies in a timely manner.

“Medical technology companies are legally required to report adverse events and often report beyond what is required by regulation, however, we welcome any moves to make this process more efficient.

“MTAA looks forward to continuing to participate in the ongoing review processes described in the Action Plan to ensure that Australians have access to the best and most innovative new technologies in order to live better and more fulfilling lives.”

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