Declaration that certain IVDs are medical devices

Therapeutic Goods (Articles that are Medical Devices) Specification 2014

18 December 2014

In December 2014 the National Manager of the Therapeutic Goods Administration signed the Therapeutic Goods (Articles that are Medical Devices) Specification 2014. The Specification ensures that pathology tests and related instrumentation, that are used for the purpose of predicting the susceptibility or predisposition of persons to a disease or ailment, are medical devices for the purposes of the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002.

The Specification also corrects a drafting oversight by specifying that pathology tests and related instrumentation, that are used to test for pregnancy in persons, are medical devices.

The Specification was recommended in the Regulation Impact Statement proposing amendments to the new regulatory framework for in vitro diagnostic medical devices (IVDs).

The Specification is intended to put beyond doubt that such goods are medical devices and to ensure that these goods can be regulated under the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 as IVD medical devices, consistent with other medical devices of comparable risk.

A copy of the instrument can be found on the Medical devices notices & standards orders page.