Oral Presentation Australian Institute of Medical Scientists National Scientific Meeting 2013

The regulation of In vitro diagnostic medical devices (IVDs) – an update on the transition to the new IVD regulatory framework (#25)

Ruth Lopert 1 , Michellelle McNiven 1
  1. Therapeutic Goods Administration, Symonston, ACT, Australia

In vitro diagnostic medical devices (IVDs) are tests and related instrumentation used to carry out testing on human samples. The results of these tests are intended to assist in clinical diagnosis and management. IVDs are typically used in diagnostic laboratories, other laboratories (blood and tissue screening laboratories), at the point of care, and in some cases in the home.

A new regulatory framework for IVDs was introduced in 2010 and comes into full effect at the end of a four year transition period on 30 June 2014. The regulations are intended to ensure that all IVDs undergo a level of regulatory scrutiny that is commensurate with the risks associated with their use.

A number of outstanding issues have been identified in relation to the regulation of IVDs under the new framework, particularly in relation to difficulties some members of the sector anticipate in achieving timely compliance with the new requirements. In response to some of these concerns the Therapeutic Goods Administration (TGA) recently released a consultation paper proposing some limited and specific amendments to the regulations and invited comment from stakeholders to assist the TGA with consideration of these issues.

This presentation will provide an update on the status of the transition of IVDs to the new regulatory framework.