Conformity assessment procedures are the processes used to demonstrate that a medical device meets Australia’s safety and performance requirements, known as the Essential Principles. These procedures are central to how we regulate medical devices. Consultation on the proposed amendments to the conformity assessment procedures is open now, until 27 February 2026. Consultation is intended to improve clarity, efficiency and alignment with international regulatory frameworks wherever possible, while continuing to support the safety and performance of medical devices supplied in Australia.
The aim of the webinar is to provide an overview of the consultation, outline the key areas where feedback is sought, and offer an opportunity for participants to ask questions.
Speaker
Dr. Tania Ahmed, A/g Director, Medical Devices Surveillance Branch, TGA
