In-House IVDs Require Conformity Assessments in Australia

Australian regulatory authorities July 1 will begin charging fees to makers of in-house IVDs.

The Therapeutic Goods Administration classifies in-house IVDs as pathology tests developed within a laboratory to carry out testing on human samples, where the results are intended to assist in clinical diagnosis or to be used in making clinical management decisions.

The agency will charge fees for IVDs beginning July 1 and will require:

• IVDs to comply with essential quality, safety and performance principles;
• A risk-based classification scheme with different levels of regulation for each class of device;
• A choice of conformity assessment procedures based on the risk classification, so manufacturers can demonstrate initial and on-going compliance with the essential principles;
• Compliance with recognized standards to demonstrate that the essential principles and conformity assessment procedures have been met; and
• Provisions for postmarket activities, including monitoring and adverse event reporting.

In-house tests developed for research purposes only — where there is no reporting of patient results — are not required to comply.