New Australian IVD Regulations start July 1. Are you ready?

After protracted consultations, negotiations and rescheduling, the new Australian IVD regulatory framework commenced on July 1st 2010.  Most IVDs were previously exempt from pre-market approval requirements, but the new system intends to provide regulation for all IVDs.  New IVD products introduced after the commencement date will need to be included on the ARTG by means of a formal application to TGA.   

For devices already on the market before 1st July, a four-year transition period will apply for manufacturers to obtain inclusion on the ARTG.  IVDs introduced on or after 1 July will need ARTG inclusion before they can be supplied.  Do you have an IVD close to market?   Acting before July 1 may buy you four years to upgrade your systems and compliance.   Time is running out for this critical regulatory decision.  Contact us  for more advice on establishing market precedent.

For detailed reviews of the new regulations see the following recently published articles by Brandwood Biomedical Senior Consultant Paul Cohen:

• The changing regulatory environment of in vitro diagnostics: implications for sponsors, manufacturers and laboratory users (published in Australian Journal of Medical Science)

• Personalised Medicine – Navigating Dx/Rx Co- development (published in Australasian Biotechnology, AusBioTech). 

Personalised Medicine: Navigating Drug-Diagnostic Co-development

The anticipated success of personalised medicine depends largely on a molecular-targeted drug having a linked, or ‘companion’, diagnostic test designed to determine precisely whether a patient will benefit from the specific treatment. Click here to read the full version of the article written by Brandwood Biomedical senior consultant Paul Cohen, published in the April edition of the Australasian Biotechnology e-journal, about the regulatory challenges of obtaining coordinated approval for both drug and diagnostic.

Or perhaps in 2010...

TGA appears to have postponed implementation of the new IVD regulations into 2010.  This follows considerable difficulty with establishing a mechanism for dealing with the large bulk of IVDs used in Australia which are imported.  There's no equivalent of the CE certificate availabe for most of these devices - as the proposed TGA system captures many IVDs which are self certified in Europe.

For more information - come along to the IVds session at Ausbiotech 2009 to hear about the latest developments in Australia and internationally in IVD regulations.  Click here to download the full conference program.

New TGA IVD Regulations by Years End

 TGA have published their plans for the long awaited new regulatory framework for IVDs. This follows the consultations conducted as part of the proposed development of the Trans Tasman ANZTPA agency arrangements. The system will be based upon a conformity assessment model with risk based classifications determining the level of regulatory review. This regulation will be implemented by bringing IVDs within the scope of the existing Therapeutic Goods Regulations (Medical Devices) 2002. This is a change in regulation without modification to the primary legislation in the Therapeutic Goods Act - there is no need to introduce a new bill and the change will be achieved by means of simply tabling the revision in parliament as a 15-day disallowable instrument. TGA plan to introduce the amendments into parliament in the third quarter of 2009 with implementation of the new system before the end of the year. As was the case for the introduction of the harmonised devices regulations, after implementation there will be a four year transition period before the new framework becomes mandatory.

Exemptions to end

Most IVDs are currently exempt from TGA regulation. This will change when the new classifications come into force. The classification and conformity assessment arrangements broadly mirror the European IVDD requirements, although the classification arrangements have some significant differences in the detail.  Click here for a detailed comparison of the new Australian and existing European IVDD classifications.

TGA/NATA joint oversight of in-house tests

Currently all in house tests – conducted entirely within a laboratory or lab network are outside of the scope of TGA regulation. Under the new arrangements TGA will require that all such tests be NATA accredited, and will directly assess the highest risk (Class 4) tests. TGA will also begin data sharing with NATA to police the new regulations.

Questions remain over third party assessment

Key questions remain about the implementation. In particular this change is set against the background of current consultation regarding implementation of third party conformity assessment in Australia. The current proposal for TGA keeps the requirement for direct TGA conformity assessment of Australian manufacturers of IVDs. However there are signs of movement. Interestingly the TGA proposal talks in terms of TGA or other acceptable manufacturer certification being required for the lower risk IVDs.

TGA have learned form the implementation of transitional arrangements from the introduction of the devices regulations. Fee structures will not penalise those manufacturers or sponsors who choose to transition early in the 4 year transition period, hopefully avoiding the last minute rush which overloaded the review capacity of TGA as the devices transition came to an end.