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Regulatory requirements for in-house IVDs
Version 2.2, September 2018
Australian laboratories that manufacture in-house in vitro diagnostic medical devices (IVDs) are required to meet regulatory requirements (that commenced on 1 July 2010) to legally supply* their in-house IVDs in Australia. The transition period for compliance with the in-house IVD framework ended on 30 June 2017.
The IVD regulatory framework has the following features:
- IVDs must comply with a set of essential principles for the quality, safety and performance of the IVD.
- A risk-based classification scheme requiring different levels of regulation for each class of device.
- There are 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.
- Compliance with recognised standards is used as a means to demonstrate that the essential principles and conformity assessment procedures have been met.
- It includes provisions for post market activities, including monitoring and adverse event reporting.
Laboratories, the Therapeutic Goods Administration (TGA) and the National Association of Testing Authorities (NATA) are involved in ensuring the regulatory requirements of in-house IVDs are met. There is a Memorandum of Understanding (MoU) between NATA and the TGA that describes the interaction, role and responsibilities of both parties in relation to the regulation of in-house IVDs.
This guidance explains how laboratories that manufacture in-house IVDs can meet these requirements.
*Supply means making the test available and reporting patient/client results of the test.