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January 15, 2026
Approximately 5 minutes
Managing Medical Device Supply Disruptions in Australia
Managing Medical Device Supply Disruptions in Australia
1. Notification Obligations for Sponsors
Sponsors of medical devices included in the Australian Register of Therapeutic Goods (ARTG) must notify the TGA of any anticipated or actual supply disruption, shortage, or permanent discontinuation that may impact healthcare delivery. This applies particularly to critical or high-risk devices where alternative options are limited or unavailable. Source: https://www.tga.gov.au/safety/shortages-and-supply-disruptions/medical-device-supply-disruptions/manage-medical-device-supply-disruption
Notifications should be submitted as soon as the sponsor becomes aware of the issue, ideally before the disruption affects supply. Early notification allows the TGA and healthcare providers to prepare and implement contingency plans.
2. What Constitutes a Reportable Disruption
A supply disruption includes:
- Shortage: when demand exceeds available supply
- Anticipated shortage or disruption due to manufacturing, distribution, or other issues
- Permanent discontinuation of supply in Australia
Sponsors are encouraged to report even if the impact is expected to be minor, as aggregated notifications help identify broader trends. Source: https://www.tga.gov.au/safety/shortages-and-supply-disruptions/medical-device-supply-disruptions/manage-medical-device-supply-disruption
3. How to Notify the TGA
Notifications must be submitted using the online Medical Device Supply Disruption Notification form available on the TGA website. Sponsors provide details such as:
- Device name, ARTG entry, model/catalogue numbers
- Nature and expected duration of the disruption
- Estimated impact on healthcare (e.g., affected patient groups, clinical areas)
- Mitigation measures in place or planned (e.g., alternative sourcing, rationing protocols)
After submission, the TGA acknowledges receipt and may request additional information. Source: https://www.tga.gov.au/safety/shortages-and-supply-disruptions/medical-device-supply-disruptions/manage-medical-device-supply-disruption
4. TGA Assessment and Response
Upon receiving a notification, the TGA assesses:
- The criticality of the device (based on intended use, risk classification, and availability of alternatives)
- Potential impact on patient safety and healthcare delivery
- Whether the disruption is isolated or part of a systemic issue
The TGA may:
- Publish shortage information on the Medical Device Shortages List (if the device is critical)
- Work with sponsors to identify and approve alternative suppliers or importation pathways
- Coordinate with state/territory health departments and healthcare providers
- Issue communications or safety alerts if necessary Source: https://www.tga.gov.au/safety/shortages-and-supply-disruptions/medical-device-supply-disruptions/manage-medical-device-supply-disruption
5. Medical Device Shortages List
For critical devices, the TGA maintains a public Medical Device Shortages List. This list includes:
- Device details
- Expected resolution date
- Mitigation advice for healthcare professionals
Inclusion on the list helps healthcare providers anticipate and manage shortages proactively. Sponsors are required to update the TGA on changes in supply status. Source: https://www.tga.gov.au/safety/shortages-and-supply-disruptions/medical-device-supply-disruptions/manage-medical-device-supply-disruption
6. Responsibilities of Healthcare Providers and Importers
While primary responsibility lies with sponsors, importers and healthcare facilities should:
- Monitor TGA communications and the Shortages List
- Report any observed shortages or impacts to the sponsor or TGA if relevant
- Implement local contingency plans (e.g., conservation strategies, alternative therapies)
7. Additional Resources and Support
The TGA provides guidance on:
- Reporting requirements
- Form access
- Contact details for the Shortages Section
Sponsors can contact the TGA via email or phone for clarification. Ongoing monitoring and collaboration between regulators, sponsors, and healthcare providers are essential to minimize patient harm during supply disruptions. Source: https://www.tga.gov.au/safety/shortages-and-supply-disruptions/medical-device-supply-disruptions/manage-medical-device-supply-disruption
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