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NATA Agreements update: Memorandum of Understanding with TGA

07 November 2017

MoU AgreementIn Vitro Diagnostic (IVD) Medical Device regulatory framework
The IVD Medical device regulatory framework comes into full effect on 1 July 2017. Administered by the TGA, the framework is designed to ensure all IVD medical devices, including in-house IVD medical devices, are to be notified to, or registered with, the TGA following a level of scrutiny commensurate with the risks associated with their use.

The TGA and NATA, in recognising the complementary nature of their respective responsibilities as regulator and laboratory accreditation authority, have reached an understanding about co-operating and exchanging information and material on matters relating to the accreditation of laboratories engaged in the manufacture of in-house IVD medical devices.

The practical outcome of the IVD Medical device regulatory framework is that post 30 June 2017, unless otherwise exempt, laboratories will not be able to offer testing using Class 1 - 3 in-house IVD medical devices unless that test is NATA/RCPA or NATA accredited and the laboratory has complied with the requirements for notification to the TGA.

Similarly, unless otherwise exempt, laboratories will not be able to offer testing using Class 4 in-house IVD medical devices unless that test is registered on the Australian Register of Therapeutic Goods (ARTG). Laboratories are required to apply to the TGA for registration of their Class 4 in-house IVDs before 1 July 2017.

It should be noted that the regulations apply to in-house IVD medical devices which have been developed from first principles, developed or modified from a published source and/or commercially supplied which have undergone modifications.

In addition, commercially supplied products sold as “Research use only” which are used by laboratories to test and report on patient samples are considered in-house IVDs (as they can affect diagnosis, treatment, or management of a patient). In these circumstances the laboratory must validate the assay as an in-house IVD for diagnostic use in line with the NPAAC Requirements. The use of disclaimers does not preclude the need for the laboratory to validate the assay.

In September 2016, NATA and TGA signed a Memorandum of Understanding (MoU) which clarifies each party’s role and responsibilities under the framework in relation to co-operation and the exchange of information.

The MoU recognises that NATA accreditation is available to any laboratory undertaking tests on human samples and that:

Under the MoU NATA has agreed to a set of undertakings which include:

Should you have any questions regarding NATAs undertakings with respect to the IVD Medical device regulatory framework please contact Tracy Fleming, Sector Manager or Andrew Griffin, Deputy Sector Manager - Legal and Clinical Services.

Should you have questions relating to the IVD Medical device regulatory framework please contact the TGA directly This email address is being protected from spambots. You need JavaScript enabled to view it. or www.tga.gov.au