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.