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Clinical evidence guidelines documents for medical devices

12 October 2021

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 clinical evidence guidelines were developed in consultation with stakeholders, taking into account submissions received. A detailed summary of responses to submissions and amendments to the document is available for interested stakeholders.

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.

Clinical evidence guidelines documents