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.
- 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
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
Web page last updated: Wednesday, 29 August 2012