July 1st – IVD Regulatory Compliance Deadline

Time is up for the manufacturers and sponsors of IVD devices in Australia. July 1^st 2015 is the deadline for the transitional period to ensure compliance with the new regulatory framework which was introduced in 2010.

Under the new framework, IVDs are regulated as a subset of medical devices. The Therapeutic Goods Regulations (Medical Devices) 2002 have been amended to include IVDs. Due to the unique nature of IVDs there are several points of difference between the regulation of IVDs and other medical devices. These include a separate classification system for IVDs and some additional essential principles specific to IVDs.

By July 1^st, IVD devices must comply with the new regulatory framework. Transitional devices must be included in the Australian Register of Therapeutic Goods (ARTG) unless exempt from entry, or being subject of an application for inclusion.

It is important to note that obsoletes entries in the ARTG that are not removed, will continue to be invoiced annually. Sponsors must request a cancellation of unwanted ARTG entries to avoid charges.

The new regulatory framework for IVD devices in Australia can be found in the Therapeutic Goods Administration (TGA) website.

http://www.tga.gov.au/overview-regulatory-framework-vitro-diagnostic-medical-devices

For any regulatory enquiries regarding medical devices and IVDs contact KD&A on +61 4 11 101 392 or email us at kdent@kdas.com.au.