To ensure the safe and effective performance of the medical devices they supply to the Australian market, the TGA is requiring sponsors to have robust systems in place. These systems involve monitoring device performance, maintaining up-to-date device information, and promptly reporting adverse events and performance issues to the agency. The MDVP pilot is specifically designed to pinpoint areas that may need improvement, with the ultimate aim of fostering proper monitoring and communication practices that bolster the ongoing safety of medical devices available to the public. This initiative seamlessly aligns with TGA's broader post-market surveillance efforts, encompassing post-market reviews, adverse event monitoring, and manufacturer audits.
Participation in the MDVP Pilot is open to all Australian medical device sponsors listed in the Australian Register of Therapeutic Goods (ARTG), and it is entirely voluntary. By volunteering for the MDVP Pilot, sponsors gain a unique opportunity to collaborate with the TGA, deepening their understanding of post-market regulatory requirements. This participation allows sponsors to assess whether their processes and procedures align with legislative requirements.
The MDVP Pilot is scheduled to run for 12 months. Participating sponsors will be invited to complete and submit the Sponsor Vigilance Self-Assessment Tool (SAT) to the TGA. The SAT is a comprehensive questionnaire that includes links to relevant regulations, aiding sponsors in gaining a clearer understanding of their post-market regulatory obligations. This tool will be instrumental in assisting the TGA in selecting sponsors for desktop audits and on-site inspections, as well as providing essential support for regulatory education and compliance.
It's important to note that the TGA will collect information throughout the SAT, desktop audit (DTA), and inspection stages exclusively for post-market surveillance. This information will be securely stored in databases for the timeframes mandated by legislation. The records management system will facilitate the retrieval of pertinent documents and track the measures taken to investigate safety concerns or instances of non-compliance observed during the MDVP pilot processes. The valuable insights collected through the MDVP Pilot will significantly influence the continuous development of this critical program, ultimately enhancing the safety of Australian patients who rely on medical devices.
The TGA is ensuring that the information collected from the sponsors will not be shared with third parties.
An information session (webinar) was held on September 14, 2023, for sponsors to learn more about the MDVP Pilot, its processes, and what to expect in the program. Sponsors who were unable to attend the information session but would like to participate in the MDVP pilot can directly contact the TGA at MDVP@health.gov.au.
References:
Medical Devices Vigilance Program - Pilot