NATA


In July 2010, the TGA introduced a new regulatory framework for all In Vitro Medical Devices (IVDs).

Where diagnostic tests have been developed or (modified) within a laboratory (or laboratory network) for testing on human samples and the results are intended to assist in clinical diagnosis or be used in making decisions concerning clinical management, these tests are classified as In-House IVDs.

In should be noted that the application of the IVD framework is not limited to medical testing laboratories, but extends to all laboratories that manufacture in-house IVDs. In-house IVDs are subject to regulatory requirements, regardless of whether the test attracts a Medicare rebate or not.

To allow time for laboratories with in-house IVDs to comply with the IVD framework, a transition period was introduced. This transition period ends on 30 June 2017.

To continue supply of their IVDs after 30 June 2017, laboratories must comply with the regulatory requirements and notify the TGA of their Class 1-3 in-house IVDs by 1 July 2017.

Laboratories with Class 4 IVDs in existence before 1 July 2016 must apply for their inclusion on the Australian Register of Therapeutic Goods (ARTG) by 1 July 2017 (unless otherwise exempt). Class 4 in-house IVDs introduced after 30 June 2016 must be included on the ARTG before determining any patient results.

The first step is for laboratories to identify all of their in-house IVDs and then classify them for notification purposes. Classification guidance can be found on the TGA website.

Laboratories are then encouraged to apply to the TGA for portal access as soon as possible to enable them to submit their notification of Class 1-3 in house IVDs by 1 July 2017.

Further information can be found on the TGA website.

 

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