HGSA News

Medical Devices - Therapeutic Goods Specification 2014

22nd Dec 14

The Therapeutic Goods (Articles that are Medical Devices) Specification 2014 has been registered on the Federal Register of Legislative Instruments and can be viewed at http://www.tga.gov.au/declaration-certain-ivds-are-medical-devices.

The Specification defines 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 clarifying that pathology tests and related instrumentation, that are used to test for pregnancy in persons, are medical devices.