Medical Device Clinical Trial Framework

Medtech has increased in complexity with emerging medical devices posing an increasingly higher risk to patient safety. 

Human Research Ethics Committees (HREC) review the scientific validity of the trial design, the balance of risk versus harm of the device, the ethical acceptability of the trial process, and is solely responsible for approving the trial. While some HRECs have solid expertise relating to medical devices, a number of others do not, as members are drawn from pharmacology, specialist medicine, and ethics backgrounds. 

The presentation will discuss the recent regulatory changes proposed by the Therapeutic Goods Administration (TGA) for clinical trials of medical devices and its impact on a practical level. 

The presentation aims to provide a comparative review of global frameworks with discussion on challenges and enablers, as well as examples on the requirements of Software as Medical Device reviews.