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Regulatory Focus™ > News Articles > Australia’s TGA Warns Joint Implant Companies about Reclassification Deadline

Australia’s TGA Warns Joint Implant Companies about Reclassification Deadline

Posted 20 February 2014 | By Louise Zornoza

Australia's Therapeutic Goods Administration (TGA) has issued a warning to hip, knee and shoulder implant companies that they will no longer be able to market their products later this year unless they submit reclassification applications for their devices.

Joint implant devices are being reclassified from Class IIb (medium risk devices) to Class III (high risk devices) as of 1 July 2014, and the TGA gave companies a two-year grace period to file reclassification applications in order to ensure that their products could remain on the market. 

TGA has reportedly notified each company of the devices that will be targeted for marketing cancellation unless a reclassification application is received by the agency in a timely manner.


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Tags: australia

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