Find information about a medical device
Find information about medical devices in Australia, including how to search the ARTG, understand regulatory requirements, report safety issues, and meet supply, labelling, and identification obligations.
Last updated
Search and verify a device
Find and confirm details of medical devices approved for supply in Australia.
-
SectionThe ARTG is the public database of therapeutic goods that can be legally supplied in Australia. You can search the ARTG to find details of therapeutic goods approved for supply.
-
PageCheck your product is a medical device that needs to be included in the Australian Register of Therapeutic Goods (ARTG).
-
PageInformation about how we regulate medical devices and how to get your medical device approved for use in Australia.
Safety and recalls
Find information on reporting issues, product safety alerts, recalls, and shortages.
-
PageFind out how to report an adverse event, including side effects from taking medicines and problems with medical devices.
-
SectionReport a problem or find information about safety, recalls and shortages.
-
PageAll adverse events reported to us are added to this searchable database.
-
PageLearn about and search the DRAC database to find the latest recalls, alerts and product corrections.
-
PageLearn how to identify and avoid counterfeit medicines and medical devices, understand the health risks of fake products, and find out how to report suspected counterfeits to the TGA.
Understand medical devices
Learn how medical devices are defined, classified, and regulated in Australia.
-
Product regulatory stageStart here to get an overview of how medical device products are regulated.
-
Decision treeUse this decision tree to work out the classification of the medical device you want to sell or supply in Australia.
-
PageMedical devices must comply with the Essential Principles. These set out fundamental safety and performance requirements.
Supply and regulation
Understand the requirements and processes for supplying medical devices to the Australian market.
-
PageGuidance on how to supply medical devices in Australia, including requirements for ARTG inclusion, application processes, sponsor responsibilities, and ongoing compliance and post-market obligations.
-
PageA step-by-step process for sponsors (official suppliers) to supply medical devices in, or export them from, Australia.
-
PageFollow the steps for manufacturers to supply a medical device in Australia, including meeting regulatory requirements and applying for inclusion in the ARTG.
Identifying devices
Access information on device identification, labelling, and patient information requirements.
-
TopicA collection of information about the implementation of medical devices Unique Device Identification (UDI).
-
PageInformation for manufacturers and sponsors on meeting medical device labelling requirements.
-
PageAll implantable and active implantable medical devices must come with patient information materials.