Greater scrutiny for in-vitro diagnostic (IVD) devices

Greater scrutiny for in-vitro diagnostic (IVD) devices

In-vitro diagnostic (IVD) device companies will soon be subjected to greater scrutiny by Australian regulator, the Therapeutic Goods Administration (TGA). The new rules bring IVDs into line with medical devices by requiring standard technical documentation (STED) and in some cases, a full quality system.

The new TGA regulatory framework applies to in-vitro diagnostic devices that are used for therapeutic purposes. For example, pathology tests and related instrumentation used to carry out testing on human samples.

“Manufactures and sponsors of IVD devices need to act now to achieve compliance and ultimately, Australian Register of Therapeutic Goods (ARTG) listings. Establishing the required documentation and supporting systems can take time, and all of this must be done in preparation for a TGA conformity assessment” says Kea Dent, of regulatory consultancy KD&A.

“The good news is that for IVDs on the market prior to 1 July 2010, a four year transition period applies, so these companies have a little more time.”

“Sponsor organisations currently supplying an overseas manufactured, CE marked IVDs to the Australian market, will most likely find the new regulations easier to comply with. Existing CE Marking certifications can be used as evidence of conformity” adds Ms Dent.

With experience in developing over 40 medical device quality systems, regulatory consultants KD&A are ready to assist IVD manufacturers in complying with the new IVD regulatory framework. Principals Kea Dent and Philippa Henning attended a recent TGA in vitro Diagnostic (IVD) regulatory framework workshop in Melbourne.

“We recommend that IVD companies start by developing a regulatory strategy. The very first step is to determine your product’s classification. From there it is possible to map out all the requirements that apply. We work closely with our clients to help them achieve compliance in the most efficient and pragmatic way possible. “