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FDAnews Device Daily Bulletin
July 23, 2012 | Vol. 9 No. 143
Australia Reclassifies Joint Implants as High-Risk Devices
Makers of hip, knee and shoulder joint implants have two years from July 1, 2012, to apply for their products to be transitioned from Class IIb to Class III devices in Australia, the Therapeutic Goods Administration (TGA) said. The agency issued the reclassification regulation earlier this month, promising to follow up with details for industry on how to meet the Class III requirements.
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