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Regulatory Focus™ > News Articles > Australian Government Proposes Bypassing TGA for Medical Devices with CE Marking

Australian Government Proposes Bypassing TGA for Medical Devices with CE Marking

Posted 22 October 2014 | By Stewart Eisenhart

Australian Government Proposes Bypassing TGA for Medical Devices with CE Marking

Content provided by Emergo Group, a medical device regulatory affairs and quality assurance consulting firm with offices worldwide.


The Australian government under Prime Minister Tony Abbott has proposed allowing domestic medical device manufacturers to register their “routine” products in the country using CE Marking certificates from European Notified Bodies.

The proposal, part of a new government position paper pushing innovation and competitiveness issues, would in essence remove Therapeutic Goods Administration (TGA) certification requirements for Australian medical devices that have already obtained CE Mark certification for sale in Europe. (See page 28 of the position paper.)

Currently, the TGA allows importation into Australia of devices from foreign manufacturers with CE Marking; domestic manufacturers that have already obtained CE Marking for their devices, however, must still register with the TGA for market authorization in Australia. As a result, “our manufacturers face more unpredictable and lengthier timeframes for regulation domestically that their overseas competitors,” according to the government’s proposal.

“What this could mean is that in Australia, importers and local manufacturers would be on the same footing,” says Dr. Mike Skalsky, Managing Director at Emergo Australia. “But remember that the TGA recently adopted a more scrutinizing approach to CE Marking from some Notified Bodies due to safety and performance issues. The duplication for local manufacturers has been one of the subjects frequently raised by the local industry bodies, so it will be interesting to see whether the government will finally act on this issue.”


(Original Post)

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