Date: Thursday, June 25, 2026
Time: 16:00 - 17:00 CET | 10:00 - 11:00 am EDT
Location: Virtual
Introduction
Bringing an AI-enabled medical device to global markets today means navigating different definitions of "AI/ML SaMD," different evidence of expectations, and different submission pathways. Every one of those rulebooks is being rewritten in real time.
This webinar gives regulatory, quality, and product leaders a practical overview of how AI-enabled medical devices are currently registered in the five major markets:
- USA — FDA 510(k), De Novo, and PCCP for AI/ML SaMD
- EU — MDR conformity assessment under the AI Act overlay
- China — NMPA registration and AI-specific guidance
- Korea & Japan — MFDS and PMDA pathways
- ASEAN — convergence efforts and country-specific routes
For each jurisdiction, we cover classification logic, the clinical and algorithmic evidence regulators expect, and the pitfalls we most often see in submissions.
You'll leave with a comparative view you can use to scope your next global launch, and a clear sense of where expert knowledge and global regulatory intelligence support from Qserve can expedite your registration timeline.
The webinar consists of a 45-minute presentation, and a 15-minute live Q&A session. Questions for the Q&A can be submitted through the registration form, by email at marketing@qservegroup.com, or during the webinar.
Learning Objectives:
- Outline the primary registration pathways for AI/ML-enabled medical devices in the USA, EU, China, Korea/Japan, and ASEAN, including how each jurisdiction classifies AI-enabled SaMD.
- Recognize the key points of divergence between the five frameworks where definitions, evidence expectations, or AI-specific requirements differ most, and what that means for a global launch.
- Identify the near-term regulatory developments (EU AI Act milestones, FDA AI/ML guidance, NMPA AI roadmap, MFDS/PMDA updates) most likely to affect AI/ML device strategy in the coming 12 months.
Who should attend?
- Regulatory Affairs leaders, managers, and specialists responsible for global submission strategy
- Quality and clinical affairs professionals who own the evidence packages and QMS elements for AI/ML SaMD
- Product, R&D, and AI/ML engineering leads who want to understand how regulatory expectations shape design and validation choices
- Strategy and business development leaders deciding which markets to prioritise for an AI-enabled portfolio
It will be particularly valuable if you are:
- Preparing your first AI-enabled SaMD submission and choosing where to launch first
- Scaling an approved AI/ML device into new markets and running into duplicate evidence work
- Reassessing your registration roadmap under the EU AI Act / MDR interaction
- Weighing whether continuous regulatory intelligence is worth the investment versus ad-hoc tracking by your team
Agenda
Introduction
US - Bingshuo Li, Active Medical Device Expert & AI-lead
EU - Bingshuo Li, Active Medical Device Expert & AI-lead
ASEAN - Dennis Sarwin, Team Manager Global Registrations & Consultant
Korea & Japan - Dennis Sarwin, Team Manager Global Registrations & Consultant