Essential Principles - consent for non-compliance
There are Criminal Offences under section 41MA and Civil Penalties under section 41MAA of the Therapeutic Goods Act 1989, for persons who import, supply or export medical devices that do not meet the Essential Principles for safety and performance.
However, there may be extenuating circumstances preventing compliance to one or more parts of an Essential Principle for a limited period of time.
In such circumstances sponsors may request consent to import, supply or export medical devices which do not meet an Essential Principle.
Where consent to supply is granted for a medical device that is non-compliant with the Essential Principles ongoing regulatory responsibilities of the sponsor remain including, but not limited to, undertaking recall action and reporting of adverse events.
How to apply for consent
To complete an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles, please complete the online application form available on the TGA Business Services (TBS) portal.
A guidance document with instructions on how to complete the consent application form can be downloaded from this page in the 'More information' section below.
How to provide submissions to notifications
Sponsors who have been granted consent to import, supply, or export medical devices that do not meet the Essential Principles are required to provide a submission to the TGA at the end of their consent period when their medical devices have returned to compliance. In addition, the TGA may request that sponsors respond to regulatory letters and other notifications related to the medical devices that are a part of a consent application.
The Consent for Non-compliance Dashboard allows sponsors to manage their consent applications as well as to provide submission during the consent period. A guidance document with instructions on how to view and respond to notifications on the Dashboard can be downloaded from this page in the ‘More information’ section below.
Webinars for the Consent for Non-compliance Dashboard
The TGA hosted two webinars to guide sponsors through the application form and new notification features in the Consent for Non-compliance Dashboard in TBS.
- Webinar 1: Application for consent to import, supply or export a medical device that is non-compliant with the Essential Principles (EPs).
Wednesday 19 October 2022, 2:00pm – 3:00pm AEST
Watch a recording of this webinar
- Webinar 2: Viewing and responding to notifications in the Consent for Non-compliance Dashboard.
Thursday 20 October 2022, 11:00am – 12:00pm AEST
Watch a recording of this webinar
To provide feedback on the application form, please complete the survey available on the TGA Consultation Hub.
The application fee for consent to import, supply, or export a medical device, including an IVD, can be found on the Fees and Charges web page.
Payment of the application fee can be made online; the options available are provided on the Payment Options web page.
Fee reduction for consent applications solely related to non-compliant information provided with medical devices (EP 13)
On 29 September and 15 December 2022, fee reductions came into effect for sponsors of ARTG entries supported by EU MDD, EU IVDD or ISO 13485 certification transitioning to EU MDR, EU IVDR or MDSAP (IVDs only) certification who seek consent to import, supply, or export devices with non-compliant labels or information (EP13).
The application fee for consent has been reduced to a flat $30 per ARTG entry where the application is made solely in relation to non-compliance with EP 13 (information supplied by the manufacturer) and the non-compliance is due to transitioning from EU MDD, EU IVDD or ISO 13485 certification to EU MDR, EU IVDR or MDSAP (IVDs only) certification. This fee reduction will be applied retrospectively to applications made from 1 January 2022 (i.e.: a refund for the difference in fees where a higher fee has already been paid by eligible sponsors). Standard fees apply for consent applications where the medical device does not comply with any other Essential Principles.
Sponsors with a consent in place who believe they are eligible for a fee refund should contact the TGA at email@example.com identifying the relevant consent application. Once the refund request is validated, it will be forwarded to the Cost Recovery Management Section team who will contact the sponsor regarding the refund.
Fee reduction for consent applications solely related to non-compliant patient information materials (EP 13A)
On 29 October 2021, amendments to the Therapeutic Goods (Medical Device) Regulations 2002 came into effect to allow greater flexibility in how patient information materials may be supplied for implantable, and active implantable, medical devices in Australia, and to provide for reduced fees for applications for consent to import, supply or export such devices if they do not comply with these requirements (to $30 per ARTG entry or application for inclusion if the application is made solely in relation to noncompliance with EP 13A).
- Guidance for completing an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles
- Guidance for viewing and responding to a notification on the Consent for Non-compliance Dashboard
- Consent for Non-compliant Medical Device(s) - Frequently Asked Questions
- Meet safety, performance and quality requirements for medical device manufacturers