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AUS: Global Harmonisation For Medical Devices

Monday, 2 August 1999

Global Harmonisation For Medical Devices Cuts Red Tape And Improves Consumer Access

The Parliamentary Secretary to the Minister for Health and Aged Care, Senator the Hon Grant Tambling, says proposed reforms to medical devices regulation in Australia will cut red-tape for industry and give better access for consumers to new and safe medical devices.

Medical devices include a range of products from heart valves, prosthetics, drug-delivery machines to bandages and dressings.

Senator Tambling told the Medical Industry Association of Australia's annual conference in Sydney that the reforms will reflect the Government's commitment to global harmonisation of regulatory standards in line with international best practice.

The reforms include a risk-based device classification system, minimum safety and performance requirements and harmonised Quality Assurance systems for manufacturing.

"Since coming into office the Government has set out to reduce regulatory duplication and assist the facilitation of trade for Australian industries," Senator Tambling said.

"Alignment of regulatory requirements will avoid unnecessary 'red tape', improve access to overseas markets and lead to excellent opportunities for Australia to maximise benefits from existing and future international agreements on medical devices.

Australia's medical devices market is worth approximately $A1.5 billion which represents about 1% of the global market.

Senator Tambling said Australian consumers are demanding the benefits of new technologies and have high expectations that medical devices are safe to use and that they have been appropriately assessed prior to supply in Australia.

"The reforms will ensure that the high quality, safety and timely availability of medical devices is maintained," Senator Tambling said.

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