Public consultation: Conformity Assessment Procedures for medical devices – Proposed amendments

These changes are 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. 

What the consultation is about

The consultation proposes changes to the existing conformity assessment procedures that are intended to:

• make requirements clearer and more consistent for manufacturers
• reduce unnecessary regulatory burden by aligning with international approaches wherever possible
• support timely access to innovative medical devices in Australia
• strengthen existing expectations for quality management and design controls, including for software and emerging technologies
• support earlier identification and management of safety and performance issues
• increase consumer and healthcare professional confidence in the regulation of medical devices.

How to participate

Give us your feedback by making a submission at our TGA consultation hub.

What are conformity assessment procedures

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.