To promote global alignment for the medical device regulatory system in Taiwan, enhance competitiveness of the domestic industry and increase international visibility, the Taiwan Food and Drug Administration (TFDA) applied to join the International Medical Device Regulators Forum (IMDRF) as an Affiliate Member in 2023. After review and meeting discussions by the IMDRF Management Committee (MC), TFDA received approval via a reply letter from IMDRF.

    IMDRF is an international organization that was established in 2011. There are currently 11 MC Members from the regulatory authorities of Australia, Brazil, Canada, China, European Union, Japan, Russia, Singapore, South Korea, United Kingdom, and the United States of America, who have come together to strategically accelerate international medical device regulatory convergence. At this time, the organization has 7 working groups that focus on adverse event terminology, artificial intelligence/machine learning-enabled medical devices, good regulatory review practices, personalized medical devices, quality management systems, regulated product submission, and software as a medical device. They develop harmonized regulatory guidances for all stakeholders to follow.

    In the future through this affiliate membership, TFDA can participate in MC meetings to find out the latest medical device regulatory strategies and trends, as well as join working groups to have information exchange on technical topics with other regulators. This may strengthen TFDA’s medical device regulatory system, help it meet emerging technical challenges that are increasingly diverse, ensure protection of public health and safety, and continue to maintain the goal of internationalization for its medical device regulation.