Sections 41MA and 41MMA of the Therapeutic Goods Act 1989 (the Act), outline criminal offences and civil penalties for persons who import, supply, or export medical devices that do not meet the Essential Principles for safety and performance.
However, extenuating circumstances may prevent a sponsor from ensuring their medical device meets one or more parts of an Essential Principle for a limited period. In such circumstances, sponsors can apply to the TGA, requesting for consent to import, supply, or export medical devices that do not meet one or more parts of the Essential Principles.
If the TGA grants consent for a sponsor to supply a medical device that does not meet one or more Essential Principles, the sponsor still has ongoing regulatory responsibilities. These responsibilities include, but are not limited to, undertaking recall action and reporting of adverse events.
Who can apply for consent
Any sponsor of medical devices can apply for consent to import, supply, or export. This includes sponsors of exempt goods like vaping devices, sponsors with pre-market applications, and sponsors with devices included in the Australian Register of Therapeutic Goods (ARTG).
How to apply for consent
To apply for consent to import, supply, or export for a medical device that does not meet the Essential Principles, please complete the online application form available on the TGA Business Services (TBS) portal.
A user guide with instructions on how to complete the consent application form can be found here: Completing an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles.
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 must provide a submission to the TGA at the end of their consent period when their medical devices meet the requirements of the Essential Principles. Additionally, 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 and provide submissions 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.
Fees
The application fee for consent to import, supply, or export a medical device can be found on the Fees and Charges web page and in Schedule 5 – Fees, Part 1 – General of the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations).
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 that do not meet Essential Principle 13 (information provided with medical devices)
The application fee, as outlined in the Fees and Charges web page has been reduced for medical devices that do not meet the requirements of Essential Principle 13 (information supplied by the manufacturer). This reduction applies when Essential Principle 13 cannot be met due to transitioning from EU MDD, EU IVDD or ISO 13485 certification to EU MDR, EU IVDR or MDSAP (IVDs only) certification.
Fee reduction for consent applications that do not meet Essential Principle 13A (patient information materials)
On 29 October 2021, the TGA amended the Therapeutic Goods (Medical Device) Regulations 2002 to allow greater flexibility in providing patient information materials for implantable, and active implantable medical devices. The amendments also included reduced fees for applications for consent to import, supply or export such devices if they did not meet the requirements of Essential Principle 13A. For the most up to date information on fees and charges, please refer to the Fees and Charges web page.
More information
- 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 medical devices that do not meet the Essential Principles
- Meet safety, performance and quality requirements for medical device manufacturers