Essential Principles - consent for noncompliance
There are Criminal Offences under S41MA and Civil Penalties under S41MAA 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 Related Information section.
The TGA hosted a webinar on 29 November 2021 to guide sponsors through the new application form in TBS. The webinar recording can be accessed via the TGA presentations webpage.
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 patient information materials (EP 13A)
On 29 October 2021, amendments to the Therapeutic Goods (Medical Device) Regulations 2002 came into effect allowing greater flexibility in how patient information materials may be supplied for implantable, and active implantable, medical devices in Australia, and providing 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).