By Stewart Eisenhart, Emergo Group

Australia’s Therapeutic Goods Administration (TGA) has published proposed changes to upcoming in vitro diagnostic (IVD) regulations for comment ahead of a proposed final implementation date of July 2014.

High-level components of the new Australian IVD regulatory scheme include:

• A four-tier, risk-based classification system (Class 1, 2, 3 and 4)
• All commercial IVDs must be included in the Australian Register of Therapeutic Goods (ARTG)
• All IVD must meet Essential Principles regarding quality, safety and performance
• Manufacturers of IVDs must apply conformity assessments to demonstrate compliance with Essential Principles
• Post-market monitoring processes

Proposed changes to the TGA IVD regulation

First, the TGA has proposed a staged transition to the new IVD regulatory system to give firms more time to ensure compliance. Manufacturers would have to submit conformity assessment certification applications to the TGA by 30 June 2014; applications for inclusion in the ARTG would have to be submitted by 30 June 2015. Alternately, manufacturers would have to apply to the ARTG by 30 June 2014.

Second, the TGA would align conformity assessments for some Class IV IVDs used by laboratories for internal testing more closely with requirements for commercial IVDs.

Third, the TGA would be authorized to undertake performance evaluations of Class IV IVDs submitted for design examination. These evaluations would be determined based on issues such as level of risk, intended use and manufacturer’s performance claims.  

Fourth, Australian regulators would redefine the definition of a medical device to include IVD tests for genetic predispositions or susceptibility to diseases. Such tests currently fall under “other therapeutic goods” in Australia.

The TGA has set a deadline of 31 May 2013 for accepting comments on its proposals. 

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.