Viewing and responding to a notification from the dashboard about an application for consent to import, supply or export medical devices that do not meet the Essential Principles

The attached User Guide document is currently under review and an updated document will be published very soon.

This user guide provides information on how to view and respond to notifications related to medical devices that are part of an application for consent to import, supply, or export medical devices that do not meet the Essential Principles.

Notifications sent from the TGA can include an informal request for additional information regarding a submitted application, letters advising of the outcome of an application submission, and regulatory letters related to medical devices that are part of an approved consent application.

User Guide

Related information

• Australian Regulatory Guidelines for Medical Devices (ARGMD)
• Essential Principles: consent for non-compliance
• Consent for medical devices that do not meet the Essential Principles
• Guidance for completing an application for consent to import, supply or export a medical device that does not comply with the Essential Principles.