RAPS runs a virtual workshop comparing US FDA, EU MDR and China NMPA regulatory pathways for AI/ML-enabled medical devices, alongside early regulatory engagement strategy — , 10:00 a.m.–2:00 p.m. EST.
Date and format
- Date: 12 November 2026, 10:00 a.m.–2:00 p.m. EST
- Format: virtual
- Organizer: Regulatory Affairs Professionals Society (RAPS)
- Registration: via RAPS's workshop page; fee not confirmed in the sources reviewed
What it covers
The workshop is designed to help regulatory and product development teams successfully bring AI- and ML-enabled medical devices to market. Participants compare global regulatory perspectives from the US FDA, EU MDR and China NMPA, working through classification pathways, documentation expectations, clinical evidence requirements and key guidance documents across the three jurisdictions. A recurring theme is the value of early and continuous regulatory affairs involvement in AI product development, aimed at reducing risk and preventing late-stage submission delays.
Who should attend
RAPS aims this at regulatory affairs and product development professionals working on AI- or ML-enabled medical devices destined for more than one regulatory jurisdiction, and anyone building an early regulatory engagement strategy for those products.
The workshop sits alongside RAPS's other 2026 device-focused sessions, including its medical device cybersecurity workshop and its combination products delivery workshop; the full events directory lists every RAPS session we have verified.
Frequently asked questions
When is the RAPS AI Medical Device Regulations workshop?
12 November 2026, 10:00 a.m.–2:00 p.m. EST, held virtually.
Who runs the workshop?
The Regulatory Affairs Professionals Society (RAPS), as part of its ongoing workshop series for regulatory and quality professionals.
What does the workshop cover?
Global regulatory pathways for AI/ML-enabled medical devices under the US FDA, EU MDR and China NMPA — comparing classification pathways, documentation expectations, clinical evidence requirements and key guidance documents — alongside early regulatory engagement strategy.
Who should attend?
Regulatory affairs and product development professionals bringing AI- or ML-enabled medical devices to market across more than one jurisdiction, per RAPS's own workshop page.
Is there a fee?
RAPS's page was not directly reachable this session to confirm member/non-member pricing. RAPS workshops of this kind are typically ticketed — check RAPS's own registration page before registering.
Sources & further reading
- RAPS. Workshop: Navigating AI Medical Device Regulations: Global Strategies and Early Engagement, 11/12/2026. raps.org
Event details are published by the organizer and can change. This listing was verified via WebSearch corroboration of RAPS's own page rather than a direct fetch, because this session's network egress could not reach raps.org directly, and only a single primary source could be found (disclosed in provenance) — confirm date, format and registration with RAPS before making plans. Last verified 18 September 2026.
