Australian Sponsors are responsible for post market surveillance by reporting Australian adverse incidents, overseas regulatory actions, and results of investigations undertaken by the manufacturer such as further clinical studies and reviews of adverse events. Adverse events and complaints are reported to the TGA and input into a database that is then reviewed by the TGA or in some cases an expert panel which may result in; recalls, hazard/safety alerts, product modification, and/or surveillance audits of manufacturing sites.
Sponsors of AIMD, Class III or implantable Class IIb devices must provide three consecutive annual reports to the TGA once the products are included on the ARTG. The reports must include all complaints received by the manufacturer relating to problems with the use of the product. Sponsors and manufacturers of devices must have procedures in place to monitor the performance of the device.
Sponsors must be able to obtain information from manufacturers in a timely manner as set out by the Regulations and ensure the maintenance of distribution records should the TGA have questions or require a recall. This is imperative for post market surveillance.
Contact Asia Actual with questions regarding post market surveillance in Australia. Our local regulatory experts are well positioned to assist.