TGA-NATA MoU relating to the regulation of in-house IVDs

The TGA and the National Association of Testing Authorities (NATA) formed a Memorandum of Understanding (MoU) in relation to In-House In Vitro Diagnostic Medical Devices.

This Memorandum of Understanding (MOU) describes the cooperative relationship between the TGA and NATA in relation to NATA-Accredited facilities that conduct services relating to the protection of public health and patient safety.

Memorandum of Understanding between the Commonwealth of Australia and the National Association of Testing Authorities, Australia in relation to In-House In Vitro Diagnostic Medical Devices

This Memorandum of Understanding is made between the

COMMONWEALTH OF AUSTRALIA, as represented by the Therapeutic Goods Administration ABN 40 939 406 804 within the Department of Health, Disability and Ageing

and the

National Association of Testing Authorities (NATA), Australia (ABN 59 004 379 748), a company limited by guarantee having its Registered Office at 7 Leeds Street, Rhodes, NSW, 2138.

["the Parties"]

A. BACKGROUND

1. The TGA has responsibilities under the Therapeutic Goods Act 1989 (the Act), on behalf of the Commonwealth, for ensuring therapeutic goods (medicines including vaccines, and medical devices, including in vitro diagnostic medical devices (IVD medical devices)), available in Australia, are of acceptable quality and safety, and perform as intended.
2. NATA was established in 1947 by the Commonwealth and the six states "to organise a national service that ;will provide testing facilities to meet the needs of government, industry and commerce". The Commonwealth and NATA entered into a Memorandum of Understanding in 1988. The current version of this arrangement dated 27 February 2024 recognises NATA as Australia's key organisation for the development of knowledge, international experience and recognition in accreditation of inspection bodies, testing and measurement laboratories, proficiency testing scheme providers and producers of reference materials. The Memorandum of Understanding also recognises NATA as the national authority for laboratory accreditation.
3. The TGA and NATA acknowledge that:
   1. the operation of NATA-accredited laboratories engaged in the manufacture of in-house in vitro diagnostic medical devices (IVD medical devices) is critical to the maintenance of the health of the public,
   2. there needs to be direct communication and the transfer of information between NATA and the TGA so that the Parties can fulfil their respective responsibilities of ensuring the device supplied is safe, performs as intended and any concerning issues that may adversely affect public health, and
   3. NATA is obliged to undertake all accreditation activities with impartiality in accordance with the requirements of ISO/IEC 17011 Conformity assessment. Requirements for accreditation bodies accrediting conformity assessment bodies.
4. The IVD medical device regulatory framework as implemented on 1 July 2010 to ensure all IVD medical devices, including in-house IVD medical devices, undergo an appropriate level of regulatory scrutiny that is commensurate with the risks associated with their use.
5. Under the framework, IVD medical devices are regulated as a subset of medical devices. The legislative basis for uniform Australian controls over medical devices is n the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the TG Regulations) and the Therapeutic Goods (Medical Devices) Regulations 2002 (the TG MD Regulations).
6. The IVD medical device regulatory framework has the following features:
   1. an IVD medical device classification scheme based on different levels of risk for each class of device,
   2. all lVD medical devices must comply with a set of essential principles that set the regulatory requirements for the quality, safety and performance of the IVD medical device,
   3. a choice of procedures (known as conformity assessment procedures), based on the risk classification, to be applied by manufacturers to demonstrate initial and on-going compliance with the essential principles,
   4. compliance with recognised international and Australian standards could be used as a means to establish that the essential principles have been met and conformity assessment procedures have been applied, and
   5. provision for post market activities, including compliance testing, adverse event reporting and recalls.
7. The regulatory requirements for in-house IVD medical devices are outlined in the guidance.
8. NATA accreditation is available to any laboratory undertaking tests on human samples. It is recognised that:
   • all medical laboratories undertaking Medicare rebated pathology tests are required to hold NATA/RCPA accreditation requiring compliance with the standard ISO 15189, Medical laboratories - particular requirements for quality and competence, as amended from time to time,
   • NATA accreditation can be granted to medical laboratories not undertaking Medicare rebated pathology tests for compliance with the standard ISO 15189, Medical laboratories -requirements for quality and competence, as amended from time to time,
   • in conjunction with assessment activities for ISO 15189, NATA undertakes an assessment of the manufacture and use of in-house IVD medical devices against the National Pathology Accreditation Advisory Council (NPAAC) Standard, Requirements for the Development and Use of In-House In Vitro diagnostic Devices, as amended from time to time, and
   • NATA is able to assess laboratories (that are outside the scope of ISO-15189) that manufacture Class 1-3 in-house IVD medical devices for compliance with ISO/IEC 17025, General requirements for the competence of testing and calibration laboratories and the NPAAC standard, Requirements for the Development and Use of In-House In Vitro diagnostic Devices as amended from time to time. Requests from laboratories for accreditation to ISO 17025 will be considered by NATA on a case-by-case basis.
9. With the need to minimise additional compliance costs and avoid duplication of effort, the regulatory requirements for in-house IVD medical devices utilise existing systems of laboratory oversight. This enables laboratories to meet the applicable conformity assessment procedures for in-house IVD medical devices provided they maintain the required accreditation with NATA and demonstrate continued compliance with the NPAAC Standard.
10. For details on regulatory requirements, refer to Schedule 3, Part 6A and 6B of the Therapeutic Goods (Medical Devices) Regulations 2002 and guidance on Manufacturing or supplying in-house in-vitro diagnostic medical devices (IVDs).