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Does the same Australian legislation apply to In Vitro Diagnostics (IVD) products?

April 26, 2017Australian Diagnostics IVD legislation products Vitro

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Does the same Australian legislation apply to In Vitro Diagnostics (IVD) products?

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From July 2010 in-vitro diagnostic (IVD) device companies will be subjected to greater scrutiny by Australian regulator, the Therapeutic Goods Administration (TGA). The new rules bring IVDs in line with medical devices by requiring standard technical documentation (STED) and in some cases, a full quality system. Please refer to http://www.kdas.com.au/IVD for more information.