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).