Public consultation for proposed changes to medical device conformity assessment procedures

Feedback can be provided through our consultation hub while the survey is open.

After the closing date, submissions will be reviewed, and a summary will be available on the same consultation page.

We are aware of recent proposed changes to the European regulations. Those proposed changes will be considered with the responses to this consultation.

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. 

About this consultation

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.
• Proposals 1-5 of this consultation focus mainly on the conformity assessment procedures relied upon for TGA conformity assessment certification, or certification by any future Australian conformity assessment body. Proposals 6, 7 and 8 also apply to medical devices certified by comparable overseas regulators.

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. However, none of the proposals in this consultation would change the way we recognise comparable overseas regulator approvals and assessments.