NATA and the Therapeutic Goods Administration (TGA) have renewed their Memorandum of Understanding (MOU), continuing their established cooperative relationship in relation to NATA-accredited facilities involved in the use of in-house in vitro diagnostic medical devices (IVDs)
The renewed agreement reinforces the important connection between accreditation, regulatory oversight and the delivery of diagnostic services that support public health and patient safety across Australia.
IVDs are medical devices used to examine samples taken from the human body and can play an important role in informing healthcare decisions. The MoU recognises the critical role of NATA-accredited laboratories engaged in the use of in-house IVDs and establishes a framework for cooperation and information sharing between NATA and the TGA.
Under the agreement, the two organisations recognise the need for direct communication and appropriate exchange of information to support their respective responsibilities. This includes addressing issues of concern that may adversely affect public health and helping ensure devices are safe and performs as intended.
The MoU builds on the longstanding relationship between NATA and the Commonwealth Government. Established in 1947 by the Commonwealth and six states, NATA was created to provide a national testing service supporting the needs of government, industry and commerce.
The current broader MoU between NATA and the Commonwealth, dated 27 February 2024, recognises NATA as Australia’s national authority for laboratory accreditation and its role in the accreditation of inspection bodies, testing and measurement laboratories, proficiency testing providers and reference material producers.
The agreement relating to in-house IVDs further demonstrates how accreditation and regulation can work together to strengthen confidence in services that have a direct bearing on the health and wellbeing of Australians.
Importantly, the MOU also recognises NATA’s obligation to undertake its accreditation activities impartially in accordance with ISO/IEC 17011, Conformity assessment – Requirements for accreditation bodies accrediting conformity assessment bodies.
Ultimately, the agreement provides a stronger foundation for cooperation between NATA and the TGA, supporting a shared focus on quality, safety and confidence in diagnostic services where reliable outcomes matter most.
You can find the full MoU document here