Information session for proposed amendments to the Conformity Assessment procedures for medical devices

Background

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 closed 27 February 2026. 

The webinar provided an overview of the consultation. 

Speaker

Dr. Tania Ahmed, A/g Director, Medical Devices Surveillance Branch, TGA 

Slides