Health regulators in Australia have made a proposal incorporating new changes in the upcoming in vitro diagnostic regulations. Changes are proposed for public comment before a planned implementation in July of 2014. The new IVD scheme comes with several significant changes in high-level components.
A new classification system will break IVDs down into four different classes based on their properties. To comply with regulations, all IVDs sold commercially must be registered in the Australian Register of Therapeutic Goods.
IVDs must be designed to certain standards of performance, safety, and quality. To ensure these quality standards are met, IVD manufacturers are required to apply conformity assessments as part of a regulatory and quality assessment inspection process.
The Australian Therapeutic Goods Administration made a proposal for a graduated change to help give impacted companies more...