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

To guide sponsors to ensure they understand and comply with their ongoing regulatory obligations after consent to supply is granted and throughout the consent period. 

At the end of the consent period, sponsors must provide evidence that the device fully meets all Essential Principles (EPs) requirements.

Consent duration and end‑of‑period expectations 

Consent to supply for devices that do not meet the EPs 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 EPs by the consent expiry (or earlier).

Requesting an extension

If your device will not meet the EPs 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, the TGA 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. 

Keeping the TGA updated about related applications

• 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.

Submitting evidence of compliance before or at the end of the consent period

Sponsors can submit evidence that their devices meet the EPs 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 EPs. 

The TGA will review the evidence provided by sponsors to ensure the device meets the EPs. 

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

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

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 
The TGA may take regulatory action if a sponsor does not submit evidence that the device meets the EPs, 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.

Implementation plans and audits

During the consent period, the TGA 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 EPs. 

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

The TGA will work with sponsors if further evidence is required.

Contact

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