​MedTech20: Interview with Prof. John Skerritt TGA started with reflections on the last 10 years which have included:

The Australian health system is still evolving and there's been lots of work done on 'transition of care'; there's been an increase focus on mental health, General Practice has been transformed with primary care being seen as a specialty; there's been a rapid uptake of tele-health and digital technologies; and the delivery of health services has become less siloed.

Under the new MDR (where all medical devices need to be re-certified) assessment will become more rigorous. This has resulted in the TGA considering data and applications from other jurisdictions to facilitate timely regulatory reviews.

The core focus of the TGA during COVID has been to facilitate access to PPE, medical devices and ventilators and to ensure continuity of operations for non-COVID related products.

Future directions involve having flexible regulatory frameworks for innovative products (eg software as a medical device and 3D printed devices) and having protocols for cybersecurity.

 

Thanks to the speakers: John Skerritt, George Faithfull