Once a medical device has been included in the ARTG, the device must continue to meet all the regulatory, safety and performance requirements and standards that were required for the approval.

The TGA has mandatory requirements for all manufacturers and sponsors of medical devices.

On this page: Adverse events | Medical devices safety monitoring

Adverse events

• Medical device incident reporting & investigation scheme (IRIS)
  The IRIS is responsible for the management of all reports of adverse events or problems associated with medical devices that are reported to the TGA
• IRIS inSite
  The IRIS inSite program works closely with health facilities to improve awareness about medical device adverse event reporting
• Database of Adverse Event Notifications (DAEN)
  Information from reports of adverse events that the TGA has received in relation to medical devices used in Australia

Medical devices safety monitoring

See the Australian regulatory guidelines for medical devices (ARGMD), Part 3, Section 22 for detailed information on post-market vigilance and monitoring requirements.

• Adverse events: Australian statistics on medical devices
  Statistics on adverse event reports relating to the use of medical devices in Australia
• Therapeutic product vigilance
  TGA's approach to therapeutic product vigilance