Consent for medical devices that do not meet the Essential Principles

Applying for consent to import, supply, or export medical devices that do not meet the Essential Principles

Applications for medical devices that do not meet the Essential Principles

All applications for medical devices that do not meet the Essential Principles should be submitted through the online application form available in the TGA Business Services (TBS) portal.

Updates made to the online application form

The updated online application form allows sponsors to submit applications for consent to import, supply, or export for medical devices that do not meet the Essential Principles. The online application form now includes exempt goods such as vaping devices, devices with pre-market applications and devices already included in the Australian Register of Therapeutic Goods (ARTG).

Use of unique identifier for marketing purposes

The unique identifier is generated when an online application form is submitted. This unique identifier is primarily used to help the TGA track devices included in the application. It cannot be used for marketing purposes.

Using the updated online application form for vaping substances, including nicotine or cannabis

The updated online application form is only applicable for medical devices, including vaping devices and vaping device accessories. It cannot be used for medicines such as vaping substances, including nicotine or cannabis. For more information on consent to import, supply, or export vaping substances, please refer to sections 14 and 14A of the Therapeutic Goods Act 1989 (the Act).

Timeline for a consent application invoice to be raised and sent to sponsors

Invoices are typically generated within five business days. If you have not received an invoice for your application after this period, please contact the Product Billing and Industry Assistance Section at accountsrec@health.gov.au.

Review timeline for a consent application

Consent applications are assessed only after all relevant fees are paid in full. The review and processing time depends on the quality of the application and the supporting information provided. If sponsors do not provide sufficient information, the review timeline will be extended. It is the sponsor’s responsibility to provide all the information needed to satisfy the TGA that consent should be granted.

Information to be provided with a consent application

It is recommended that sponsors provide the following information with their application to ensure a prompt review:

• identify all relevant Essential Principles that are not met
• supply numbers, including batch or lot numbers where relevant
• consent period (from-date and to-date) during which devices will not meet the Essential Principles
• circumstance explaining why the devices do not meet the Essential Principles
• potential for supply shortage if consent is not granted, including impact on immediate and future supply
• all potential risks associated with not meeting the Essential Principles
• steps taken to address or mitigate the risks associated with not meeting the Essential Principles (risk mitigation strategies) during the requested consent period
• strategies to rectify not meeting the Essential Principles and the expected timeframe for implementation and compliance.

Duration of consent to supply devices that do not meet the Essential Principles

Consent is granted case-by-case for a limited period for devices that do not meet the Essential Principles. Consent is generally not granted for a period longer than two years. Sponsors must achieve compliance with the Essential Principles on the date or before the consent period expires.

Extension requests for an approved consent application

If the devices cannot meet the Essential Principles before the consent period ends and sponsors wish to supply their devices beyond this period, they should submit a new application via the TGA Business Services (TBS) portal. It is essential to submit the new application before the current one expires to ensure compliance with sections 41MA and 41MAA of the Act.

In extenuating circumstances, the TGA may consider extension requests for existing applications case-by-case.

Updating the TGA on the status of a consent application, relating to devices that are part of an application for inclusion

The TGA’s processes will ensure that the section reviewing the application for inclusion is informed about the consent application, the decision, and the notification sent to the sponsor.

Updating the TGA on the status of an application for inclusion that is linked to an approved consent application

If your application for inclusion is approved and your device is included in the ARTG, you should contact the TGA at mdconsent@health.gov.au identifying the relevant consent application, the application for inclusion application number, and the new ARTG entry for the recently included device. The TGA will then update the consent with the new ARTG entry and issue an updated letter for consent to supply.

Updating the TGA on reclassified devices with new ARTG entries linked to an approved consent application

Sponsors with an approved consent application for a reclassified ARTG entry should contact the TGA at mdconsent@health.gov.au identifying the relevant consent application, and ARTG entry. You do not need to reapply for consent. The TGA will provide approval for the new ARTG entry for the same approved duration.

Submitting evidence of meeting Essential Principles at the end of the consent period

Sponsors must submit evidence of meeting the Essential Principles at the end of the consent period via the TGA Business Services (TBS) portal. For more information, please refer to the Consent for Non-compliance Dashboard guidance document on the TGA website.

Applying for consent to supply while waiting for a decision on a Device Change Request (DCR)

Sponsors can submit a consent application for devices that do not meet the Essential Principles to continue their supply. However, these devices cannot be supplied until the TGA reviews and approves the consent application. The TGA cannot guarantee that consent will be approved prior to the Device Change Request being approved.

Fees

The application fee for consent to import, supply, or export medical devices, IVDs and vaping devices 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), and 13A (patient information materials)

The application fee is outlined in the Fees and Charges web page, including reduced fees for applications made solely in relation to Essential Principle 13 and 13A.

Implementation plans

Auditing of implementation plans at the end of the consent period

The TGA will use a risk-based approach to audit selection of implementation plans during the consent period to ensure they meet the requirements and are appropriately applied. Sponsors may be contacted and asked to provide additional information, where necessary. At the end of the consent period, the TGA expects sponsors to provide evidence that their devices meet the Essential Principles requirements.

Types of evidence required to demonstrate compliance with the implementation plan

While each sponsor and manufacturer’s situation are different and the types of evidence will vary, the TGA will collaborate with sponsors case-by-case if further evidence is required.

Electronic Patient Implant Cards (PICs) and Patient Information Leaflets (PILs)

Electronic patient implant cards and patient information leaflets must include all required information as outlined in the Regulations and be readily accessible to patients. To ensure patient information materials meet the Essential Principles, sponsors or manufacturers need to provide clear directions or guidance to ensure patients can readily access this information.

Device specific

Patient implant cards and patient information leaflets for resorbable sealants and haemostatic agents

Patient implant cards and patient information leaflets are required for devices that are resorbed over a period of six months or more. These patient information materials must meet the requirements outlined in Essential Principle 13A.2 and 13A.3.

Transition from European Union Medical Device Directives (EU MDD) to European Union Medical Device Regulations (EU MDR)

Using a consent application to notify the TGA about the manufacturer’s EU MDD certification that is no longer valid

Please use the form and guidance for lapses in conformity assessment certification to notify the TGA about the manufacturer’s EU MDD certification that is no longer valid.