TGA initiates new program for medical device oversight

MedTech & Diagnostics News: The Therapeutic Goods Administration (TGA) has unveiled an ambitious pilot program aimed at monitoring of medical device performance and ensuring robust product safety measures.

The TGA took its first stride towards this transformative initiative in April 2022 when it released guidelines on the post-market responsibilities of medical device manufacturers and sponsors. This document received an update earlier this year, further emphasising the importance of post-market vigilance. It explicitly outlines the necessity for sponsors to receive, update, and maintain crucial information about their products while mandating the reporting of adverse events and performance issues to the TGA.

In a notable move, the TGA is now set to embark on a pioneering pilot program, which will serve as a complementary facet to its existing post-market surveillance endeavours. The administration aims to empower sponsors and enhance their understanding of their post-market regulatory obligations, thereby fortifying the safety net surrounding medical devices in the country.

Elaborating on the program, the TGA stated, “Sponsors who voluntarily participate in this program will have the unique opportunity to collaborate with the TGA. Through this engagement, they will gain invaluable insights into their post-market regulatory requirements, ultimately enabling them to assess the adequacy of their processes and procedures in ensuring compliance with legislative mandates.”

As part of the pilot program, the TGA is inviting sponsors keen on participating in this transformative 12-month journey to complete and submit the Sponsor Vigilance Self-Assessment Tool (SAT). This comprehensive questionnaire, complete with links to relevant regulations, serves as a guide for sponsors, helping them navigate their post-market obligations.

The TGA has committed to deploying the information gleaned from these submissions to select sponsors for in-depth evaluations, including desktop audits, onsite inspections, or a combination of both. This process, according to the TGA, is designed to “support regulatory education and compliance.”

Furthermore, the insights gained from this pilot program are set to play a pivotal role in shaping the future trajectory of medical device safety oversight in Australia. The data collected during this initiative will significantly enhance the safety of Australian patients relying on medical devices, the TGA said.

To provide interested sponsors with a deeper understanding of the Medical Devices Vigilance Program (MDVP), the TGA has scheduled an information webinar for September 14, 2023.

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