The new Australian regulatory framework for in vitro diagnostics has been published into law and will apply from 1 July. It provides a four-year transition period for IVDs under the current regulatory framework to comply with the new requirements1-3.
The new IVD framework will be implemented through two regulations – the Therapeutic Goods (Medical Devices) Amendment Regulations 20104 and the Therapeutic Goods Amendment Regulations 20105 – that amend the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Regulations 1990, respectively...
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