Medical device supply disruptions or shortages
Find out how we monitor and support medical device supply disruptions or shortages in Australia.
We monitor medical device supply disruptions or shortages across Australia and work closely with State and Territories, healthcare professionals and sponsors to reduce the impact on patients. Disruptions or shortages can be caused by multiple reasons such as natural disasters, manufacturing issues, transportation issues, sudden increases in demand or a product being discontinued.
If you are a sponsor, we encourage you to notify us at the earliest convenience about potential disruptions or shortages. This will assist healthcare facilities to plan and mitigate affects to patient care. You may be asked for information in short timeframes so we can coordinate nationally.
If you’re a healthcare professional, exercising your clinical judgement will assist with deciding treatment options and helping patients find alternatives when needed.
If you’re a patient, you should speak to your healthcare providers about alternative devices when needed.
About medical device supply disruptions or shortages
If a medical device is impacted by a supply disruption or shortage you may like to explore options for alternative supply, including our schemes.
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Managing a medical device supply disruption or shortage
Find out how to manage a medical device supply disruption or shortage if you're a sponsor, consumer, healthcare facility or professional. -
Accessing unapproved therapeutic goods tool
Health practitioners, use this guide to determine which pathway, including the Special Access Scheme (SAS) and Authorised Prescriber (AP) Scheme, is appropriate to use. -
Personal Importation Scheme
Individuals can legally import most therapeutic goods for personal use under the Personal Importation Scheme, provided certain conditions are met. -
Supplying and/or importing medical devices during critical supply disruptions
Approvals under section 41HD enable sponsors to import and supply specific medical devices during supply emergencies under special exemptions and conditions. -
Supplying and/or importing medical devices during supply disruptions or shortages
Guidance to help applicants understand what a section 41HD application is, how to submit an application, and what evidence will be needed. -
Reporting potential medical device supply disruptions or shortages
Information about how to report a medical device supply disruption or shortage