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www.fdanews.com/articles/130558-australia-explains-new-ivd-regs-in-a-series-of-new-guidances

Australia Explains New IVD Regs in a Series of New Guidances

September 24, 2010
In vitro diagnostics (IVDs) marketed in Australia will be placed in one of four risk-based categories based on the Global Harmonization Task Force model, according to a new guidance on classification. However, Australia’s Therapeutic Goods Administration cautions that the categories may diverge from that of other countries, so manufacturers should take into account Australian legislation when determining the classification of a device for that market.
International Medical Device Regulatory Monitor