Application for consent to import, supply or export a medical device that does not comply with the Essential Principles: Non-compliant Patient Information Materials

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.

Please note that if your non-compliant device(s) is currently part of an application to vary the device or manufacturer’s evidence, or have an Application for Inclusion in the ARTG, you will still need to apply for consent to be able to import, supply or export the device(s) if they are non-compliant with the EPs.

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. It 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.

This form can only be used for device(s) that are non-compliant with the same parts of 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)

Each application form can accommodate up to 100 ARTG entries or Applications for Inclusion. If you are seeking consent for more than 100 ARTG entries or 100 Applications for Inclusion you will be required to complete multiple forms to complete your application for consent or you can upload a Microsoft Excel spreadsheet with a list of the ARTG number(s) or Application for Inclusion number(s). If you choose to submit multiple forms as part of the same application for consent, these will be linked during processing using the response ID generated for each form.

Click on the link at the bottom of this page to access the application form. Doing so will take you to the landing page titled ‘Contents’ from where you can select a page to enter information. You may begin by providing information about the applicant by answering questions on ‘Applicant Details’ page. Once completed, clicking 'Continue' will return you to the landing page. From here, you can select another page for entering information.

Processing Fees:

• On 29 October 2021, amendments the Therapeutic Goods (Medical Device) Regulations 2002 came into effect providing for reduced fees for applications for consent to import, supply or export medical devices that are non-compliant with Essential Principles related to patient information material.
• The application fee for consent has been reduced where the application is made solely in relation to non-compliance with EP 13A.2 and/or 13A.3 (patient information materials). Fees are now a flat $30 per ARTG entry / Application for Inclusion within the application. 
• 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 100 ARTG entries/Applications for Inclusion, please submit all forms within 24 hours.
• 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 link 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.

Concession Fees Refund:

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 19 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 related to patient information material. 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.