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Evaluation ViewAttendees 2

Pre-Conference Workshop

Medical Devices

Pre-Conference Workshop: Global Regulatory Pathways - US, China and South Korea

Tuesday, May 5, 2026
08:30 - 16:00 WEST
Location: Pavilion 5 - Room 5A
Learning Level: Advanced
Click here to download the agenda

Description: China and South Korea are two of the most desirable markets outside the US and EU. Software, AI and machine learning (ML) devices are extremely challenging globally due to fast evolving technology, uncertain clinical applications, cyber security and ethical concerns, etc. While the US and EU are developing their regulations for these emerging technologies, China and South Korea are charging ahead with its AI/ML technologies that have definite impact the device industry, and the regulations as a result.

This workshop will take a closer look at the current and near-future regulations, pathways and requirements by the US (FDA), China (NMPA) and South Korea (MFDS) for traditional medical devices as well as the innovative devices in software, AI and ML technologies. This workshop will attempt to provide a holistic view on the topics to provide attendees with comprehensive information and skills to be ready for the global regulatory challenges. This workshop is led by three subject-matter experts, who focus on the above-mentioned countries and technology. They have a combined 80 years of experience in the regulatory profession.

Learning Objectives:

  • Upon completion, participants will be able to navigate the current regulatory frameworks in the US, China and South Korea pertaining to medical device approvals/registrations, gain an in-depth understanding of the general requirements for product approval, technical requirements and clinical evidence, as well as other available pathways, their scopes, advantages and constraints.
  • Upon completion, and with special emphasis on SaMD, AL/ML products, participants will learn and understand the current regulations, pathways and technical requirements at US FDA, China NMPA and South Korea MFDS pertaining to these types of devices, and gain practical advice and valuable insights on working with regulators during consultations, Q&A sessions and final responses.
  • Upon completion, participants will be equipped with a holistic view of each country's regulatory framework to form a realistic global strategy for a conventional medical device or an innovative device. The information from this workshop will form a foundation for the participants to build on as they follow the ever-changing regulatory landscapes in different countries.