Medical devices safety monitoring
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.
See the Australian regulatory guidelines for medical devices (ARGMD), Part 3, Section 22 for detailed information on post-market vigilance and monitoring requirements.
Web page last updated: Friday, 25 March 2011
URL: http://www.tga.gov.au/industry/safety-monitoring-devices.htm