Medical devices regulatory framework reforms
The Therapeutic Goods Administration (TGA) is inviting the Australian public and industry to contribute their ideas on improving the way medical devices are regulated in Australia.
Medical devices include a wide range of products such as medical gloves, bandages, syringes, condoms, contact lenses, in vitro diagnostic devices, X-ray equipment, surgical lasers, pacemakers, dialysis equipment, and heart valves.
Medical devices can be complex and high risk, while many others are low risk but all are designed to enhance people’s quality of life.
The TGA is Australia’s watchdog on the safety and effectiveness of medicines and medical devices and, as part of its reform agenda, the TGA is seeking public input into how its regulatory processes, including transparency about its decisions, meet the expectations of the public and of the industry it regulates.
This follows a recommendation for an enhanced regulation of medical devices by the Review of Health Technology Assessment in Australia, released by the Australian Government in February 2010.
As part of this process, the TGA held public hearings in Canberra, Sydney, Adelaide and Melbourne throughout November and there is an opportunity for people to make written or online submissions to be received by 17 December, 2010.
As technology advances and the population ages, many more Australians are using high-risk medical devices, such as joint implants, implantable pacemakers and breast implants and people are looking to the TGA to provide them with confidence in the safety and performance of imported devices while reducing the regulatory burden on Australian manufacturers of lower risk medical devices.
The TGA has outlined its proposals in a discussion paper which also takes into consideration the concerns of major regulators in other countries about the way medical devices are regulated in the global context.
More information can be found at http://www.tga.gov.au/consult/index.htm
