You may experience outages and temporary issues related to medical devices adverse event reporting and access to the Database of Adverse Event Notification (DAEN)- medical devices due to scheduled maintenance around 10am-12pm AEST on 25 August and 1 September 2023.
The Database of Adverse Event Notifications - medical devices contains information from reports of adverse events that the TGA has received in relation to medical devices used in Australia.
The DAEN – medical devices does not contain information about adverse events related to medicines, which is instead accessed through the DAEN – medicines.
DAEN – medical devices: quick guide
- About the DAEN - medical devices
Learn more about the Database and its limitations - Consumer questions and answers: DAEN - medical devices
Find answers to commonly asked questions about the DAEN - medical devices. - Instructions for searching the DAEN - medical devices
Learn how to generate and use your search results. - About the search results: DAEN - medical devices
Find information about the data contained in the two types of search results from the DAEN - medical devices.
Safety monitoring and adverse events
- Overview of how TGA manages medical device adverse event reports
A look at TGA's medical device event report process. - TGA safety monitoring of medical devices
Find out how the TGA monitors medical devices and detects potential safety concerns in addition to receiving adverse event reports. - Adverse event monitoring internationally
Find out about other medicine and medical device regulators and where to access their adverse event databases.
Naming and grouping conventions
- Global Medical Device Nomenclature - GMDN
Guidance on Global Medical Device Nomenclature (GMDN) Terms for medical devices (including in vitro diagnostic (IVD) medical devices).