16 April 2015

Amendments to the new regulatory framework for in-vitro diagnostic medical devices – Regulation Impact Statement – Department of Health

On 17 October 2014, the Australian Government announced amendments to the regulatory framework for in-vitro diagnostic medical devices (IVDs) to overcome previously unanticipated problems when previous regulatory changes were introduced in 2010.

IVDs are pathology tests and related instrumentation used to carry out testing on human samples. They are typically used in diagnostic pathology laboratories, other laboratories (blood and tissue screening laboratories), at point of care, and in some cases, in the home. The safety and quality of IVDs are regulated by the Therapeutic Goods Administration (TGA). Prior to 2010, the level of IVD regulation in Australia was very limited. Changes to the regulatory framework were introduced in 2010 that require all IVDs to undergo a level of regulatory scrutiny that is commensurate with the risks associated with their use.

Prior to its full implementation, however, a number of previously unanticipated issues with the new framework were identified. These included:

  • difficulties some members of the sector were experiencing in meeting the timeframe for existing IVDs to be registered on the Australian Register of Therapeutic Goods (ARTG);
  • difficulties Australian laboratories were experiencing in meeting the regulatory requirements for higher-risk (Class 4) IVDs; and
  • the unintended omission of susceptibility and predisposition tests from the regulatory framework.

The proposed changes address these problems. In particular, the proposed changes to the regulation of Class 4 in-house IVDs are expected to allow for the continued supply of these IVDs, which was not assured under the July 2010 changes.

The proposed rule changes have been assessed as likely to have a measurable but contained impact on the economy with minor impacts on competition. A Regulation Impact Statement (RIS) canvassing the proposed changes was prepared and certified by the Department of Health consistent with Australian Government best practice regulation requirements, and the OBPR notes that the process followed by the department and the level of analysis contained in the RIS was consistent with best practice.

The RIS estimates a small (approximately $100,000 per annum) average annual regulatory cost saving. The OBPR has agreed to the regulatory cost saving.

The RIS can be downloaded from the TGA website.

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