Completing 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 successfully complete and apply for consent to import, supply, or export medical devices that do not meet the Essential Principles.

We have modernised the consent application process, moving from a paper form to an online form. The new form, hosted in the TGA Business Services (TBS) portal streamlines the application process and allows for greater functionality, including the ability for sponsors to view their current and previous applications for consent.

The TGA expects medical devices to meet the requirements outlined in the Essential Principles. However, there may be extenuating circumstances where the medical device does not meet one or more parts of an Essential Principle. In such circumstances, the TGA may grant a sponsor consent to import, supply, or export medical devices that do not meet the Essential Principles for a limited period.

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 viewing and responding to a notification on the Consent for Non-compliance Dashboard