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

Overview

This form is no longer in use. Please refer to the TGA website to complete an application for consent to import, supply, or export a medical device that does not comply with the Essential Principles.

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, unless consent has been granted by the Secretary of the Department of Health.

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

In seeking consent an authorised representative of the sponsor needs to:

• Complete and submit this application form for consent to import, supply or export a medical device that does not comply with the Essential Principles;
• Attach all the relevant documentation; and
• Pay applicable processing fee.

The delegate of the Secretary will take all relevant information into consideration when determining whether to grant consent.

About this form:

This application form is for consent to import, supply or export a medical device that does not comply with the Essential Principles.

This form can also be used to seek consent for devices which have a valid application for inclusion in the ARTG. When completing the form for these devices, please use the full application for inclusion number instead of the ARTG number.

Please complete one ‘page' (i.e. ARTG/Application for Inclusion - 1) for each ARTG entry/Application for Inclusion requiring consent. Each page contains fields for collecting details for one ARTG entry/Application for Inclusion. Once completed, clicking 'Continue' will return you to the landing page titled 'Contents'. From here, you can select another page for listing additional ARTG entries/Applications for Inclusion.

Each application form can accommodate up to 20 ARTG entries/Applications for Inclusion. If you require consent for more than 20 ARTG entries/Applications for Inclusion, please complete another form and they will be linked during processing.

Application form for consent for devices that does not comply with the Essential Principle 13A

Use this alternative form if you are requesting consent for devices that are non-compliant to Essential Principle 13A, and have same:

• Proposed duration of the consent; and
• Strategies to mitigate non-conformance, such as,
  • implementation plan,
  • non-compliant Patient implant card (PIC), and
  • non-compliant Patient information leaflet (PIL)

The alternative form can be accessed through this link.

Processing Fees:

• The processing fees apply to each ARTG entry/Application for Inclusion included in the application. The fees are $500 for the first ARTG entry/Application for Inclusion, and then $100 for each subsequent ARTG entry/Application for Inclusion.
• Fees are calculated using the total number of ARTG entries/Applications for Inclusion in the consent application, regardless of the number of forms submitted as part of the application.
• If you are submitting multiple forms due to having more than 20 ARTG entries/Applications for Inclusion, please submit all forms within 24 hours, to avoid the initial $500 fee for the first ARTG entry/Application for Inclusion being applied to subsequent applications for consent.
• There are two ways to pay the processing fees for the consent application.
  • IMMEDIATE PAYMENT – You can pay the processing fees for your consent application immediately after completing and submitting the application. To do this, you have to calculate the total fees for your application based on the number of ARTG entries or Applications for Inclusion, and use this like to pay. If you choose this payment option, please ensure that you only pay the fees after the submission of your final form in the application.
  • PAYMENT AGAINST INVOICE - If you require the TGA to raise an invoice for payment, complete and submit your application for consent, and the TGA will raise and send the submitter an invoice for the processing fees.

Fee reduction for sponsors seeking consent for non-compliant patient information materials

On 29 October 2021, changes to the Therapeutic Goods (Medical Devices) Regulations 2002 came into effect to introduce a fee concession for sponsors of implantable devices seeking consent to import, supply, or export their devices where they do not have compliant patient information materials. The application fee has been reduced to a flat fee of $30 for each ARTG entry and Application for Inclusion where the application is made solely in relation to non-compliance with EP 13A.2 and/or 13A.3.

The TGA will apply this fee concession retrospectively, refunding the difference in fees to eligible sponsors with consent in place on or after 1 January 2021. Sponsors with a consent in place who believe they are eligible for a fee refund should contact the TGA at mdconsent@health.gov.au identifying the relevant consent application. If the refund request is validated, it will be forwarded to the Product Billing and Industry Assistance team who will contact you regarding the refund.

For more information, please refer to the guidance documents, also available at the bottom of this form.

Webinar:

TGA hosted a webinar on 20 October 2021 to guide sponsors through this application for consent to import, supply or export a medical device that does not comply with the EPs. To watch a recording of this presentation please visit the TGA website.

Some common questions and answers regarding the consent to supply application process have been compiled and can be found here.

Please note:

• This application form is being hosted on a consultation platform, however it is not a consultation and none of the information that you provide in the form will be published.
• This form, when completed, will be classified as 'For official use only'. For guidance on how your information will be treated by the TGA see: Treatment of information provided to the TGA.