Consent to supply for medical devices that do not meet the Essential Principles: responsibilities after consent is granted

Consent to supply for devices that do not meet the Essential Principles is granted on a case‑by‑case basis for a limited period. Consent is generally no longer than two years. 

Sponsors must ensure the device meets the Essential Principles by the consent expiry (or earlier).

If your device will not meet the Essential Principles before the consent period ends, and you need to continue supply, you must submit a new application via the TGA Business Services (TBS) portal before the current consent expires. 

This is required to remain compliant with sections 41MA and 41MAA of the Therapeutic Goods Act 1989 (the Act). 

In some circumstances, we may consider an extension request for existing applications case‑by‑case. 

For example, an extension may be granted if there is remaining device stock, the non-compliance relates to EP 13.2 or a similar EP requirement, and the device is still within its validated shelf life. 

• Let us know if your application for inclusion is under review: the assessing area will be notified of any related consent applications and outcomes.
• If your application for inclusion is approved and the device is now in the ARTG: email mdconsent@health.gov.au with your consent application identifier, the application for inclusion number, and the new ARTG entry so we can update your consent letter.
• If your ARTG entry has been reclassified and you hold an approved consent for the previous entry email mdconsent@health.gov.au with the relevant consent application and ARTG entry details. You do not need to reapply; approval will be issued for the new ARTG entry for the same approved duration.

Sponsors can submit evidence that their devices meet the Essential Principles at any time before the consent period ends. 

At the end of the consent period, sponsors must provide evidence confirming their device now meets the Essential Principles. 

We will review the evidence provided by sponsors to ensure the device meets the Essential Principles. 

If the evidence is sufficient, the consent to supply application will be marked as completed. 

If the evidence submitted is insufficient, we will request additional information from the sponsor to support their claim that their device meets the Essential Principles. 

Use the Consent for Non‑compliance Dashboard in the TBS portal to lodge submissions and respond to regulatory letters or notifications related to your consent:

• TGA Business Services (TBS) portal.
• Dashboard user guide: Viewing and responding to a notification from the dashboard about an application for consent to import, supply or export medical devices that do not meet the Essential Principles.

Important 
We may take regulatory action if a sponsor does not submit evidence that the device meets the Essential Principles, or if non-compliance continues beyond the consent period without formal TGA approval. 

Regulatory action can include suspension or cancellation of the ARTG entry or issue of an infringement notice.

During the consent period, we will use a risk‑based approach to select and audit implementation plans to ensure they are appropriate and properly applied. 

Sponsors may be asked to provide additional information. 

At the end of the consent period, sponsors are expected to provide evidence that the device meets the Essential Principles. 

The type of evidence will vary depending on the device and specific circumstances. 

We will work with sponsors if further evidence is required.

For other consent‑related queries, email mdconsent@health.gov.au.