Medical devices safety

Related information

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.

Adverse events

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.