These documents are intended to provide guidance to manufacturers of medical devices (including in vitro diagnostic medical devices (IVDs)) on what constitutes clinical evidence and the process of clinical data generation and clinical evaluation to produce such clinical evidence.
The guidelines take into account requirements of the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002, and align with international guidance documents including those of the Global Harmonization Task Force (GHTF) and the European Commission 'MEDDEVs' which are also based on the GHTF guidelines.
In 2020, the TGA published supplementary clinical evidence guidelines related to IVD medical devices.
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.