Australia's Therapeutic Goods Administration (TGA) has opened a consultation on proposed amendments to the new regulatory framework for in vitro diagnostic devices (IVDs) that covers both commercially manufactured IVDs and in-house IVDs (those IVDs developed or modified by providers for use in their own laboratories).

Under the new regulatory framework, IVDs are deemed to be medical devices and, unless exempt, must fully comply with the new regulatory requirements as of 1 July 2014. The consultation focuses on four key issues that were identified during the first two years of the transition period (July 2010 to July 2012) leading up to the implementation of the new IVD regulatory framework.

These issues are the:

• Ability to meet the timeframe for valid applications for inclusion in the Australian Registry of Therapeutic Goods (ARTG);
• Capacity to comply with the new regulatory requirements for Class 4 in-house IVDs;
• Omission of the provision for performance evaluations for design examinations; and
• Omission of tests for predisposition or susceptibility to disease from the definition of a medical device.

The deadline for comments is 31 May 2013.

 

TGA Amendments to IVD Framework

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