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Regulation impact statement: Amendments to the new regulatory framework for in vitro diagnostic medical devices (IVDs)

Version 1.0, October 2014 - OBPR Reference: 14631

17 October 2014

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As noted above, the objective of the new regulatory framework for IVDs is to ensure that IVDs undergo a level of regulatory scrutiny that is commensurate with the risks associated with their use and that these products are regulated in a proper and appropriate manner that gives the public confidence in the quality, safety and performance of these IVDs.

However, the new framework was certainly not intended to give rise to a situation in which critical laboratory tests became unavailable (in Australia) because the regulatory requirements were too onerous for the IVD sector to be able to comply within the legislated timeframes. The new framework was also not intended to exclude IVDs used to diagnose predisposition or susceptibility to disease.

The objective of the proposals to amend the new regulatory framework for IVDs is therefore to:

  • reduce the regulatory burden on commercial and in-house manufacturers of IVDs and provide them with sufficient time to comply with the new regulatory requirements
  • reduce the regulatory burden on Australian IVD manufacturers and ensure they are no longer disadvantaged compared to their overseas counterparts
  • enable laboratories to comply with the new regulatory requirements while still maintaining an appropriate level of regulatory oversight of Class 4 in-house IVDs within a reasonable timeframe and without compromising the health and safety of Australians
  • ensure the continued availability of Australian manufactured human biological products for transfusion and transplantation (e.g., organ transplants, human blood, blood components, corneal transplants, heart valve transplant, bone products) and
  • correct unintended oversights such as the regulation of tests for predisposition and susceptibility to disease in a manner that reflects the level of risk the outcomes of these tests represent.

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