Completing an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles

This user guide provides information on how to successfully complete and submit an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles (EPs).

The TGA has 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 allow for greater functionality, including the ability for sponsors to view their current and previous applications for consent.

There are criminal offences under section 41MA and civil penalties under section 41MAA of the Therapeutic Goods Act 1989 (the Act), for importing, supplying, or exporting medical devices that do not meet the Essential Principles (EPs) for safety and performance, unless consent has been granted by the Secretary of the Department of Health and Aged Care.

The TGA expects compliance with the EPs, however there may be some extenuating circumstances preventing compliance to one or more parts of an Essential Principle for a limited period of time.

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Related information

• Australian regulatory guidelines for medical devices (ARGMD)
• Consent for Non-compliant Medical Device(s) - Frequently Asked Questions
• Guidance for viewing and responding to a notification on the Consent for Non-compliance Dashboard