FDAnews Device Daily Bulletin

Australia’s TGA Moves Joint Implants to Highest-Risk Classification

Aug. 20, 2012
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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, according to the Therapeutic Goods Administration (TGA). The agency issued the reclassification regulation last month, promising to follow up with details for industry on how to meet the Class III requirements.
International Medical Device Regulatory Monitor