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Medical devices safety

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 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

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.

• Therapeutic product vigilance
  TGA's approach to therapeutic product vigilance is to continually monitor and evaluate the safety and efficacy (performance) profile of therapeutic products and to manage any risks associated with individual products