Taiwan FDA Re-Elected as Chair of GHWP WG3, Driving Global Harmonization of Software as a Medical Device Regulations

  The Taiwan Food and Drug Administration (TFDA) has been re-elected as Chair of the Global Harmonization Working Party (GHWP) Working Group 3 (WG3) on Pre-market: Software as a Medical Device (SaMD). This renewed mandate underscores Taiwan’s leadership in advancing international regulatory convergence, particularly in the rapidly evolving field of artificial intelligence (AI)-enabled SaMD.   GHWP WG3 plays a pivotal role in shaping global regulatory frameworks for SaMD, including AI/ML-based technologies that are transforming healthcare delivery. Under TFDA’s chairmanship, the group has successfully developed guidance documents and white papers that support regulators, industry, and healthcare providers in ensuring patient safety while fostering innovation.   The re-election reflects the confidence of GHWP members in TFDA’s ability to continue steering collaborative efforts. Over the past term, WG3 has made significant progress in clarifying definitions, risk categorization, and lifecycle management approaches for AI-driven SaMD. These achievements have laid the foundation for greater alignment among regulatory authorities across Asia, South America, an...