RAPS Workshop: Navigating Global Medical Device Inspections: Expectations from US, EU, China, Korea, and Japan

Device inspections don't run the same way twice across borders, and RAPS puts the differences side by side in one live session on 27 October 2026 — comparing FDA, EU (including MDSAP), China's NMPA, South Korea's MFDS and Japan's PMDA inspection expectations, trends and documentation requirements through worked case studies.

Dates and format

• Date: 27 October 2026, 10 a.m.–2 p.m. ET
• Format: virtual, 4-hour live workshop
• Organizer: Regulatory Affairs Professionals Society (RAPS)
• Pricing: early bird $315 member / $370 non-member through 27 September 2026; $370 / $430 regular

What it covers

The workshop walks through how device inspections actually run in five jurisdictions — the US FDA, the EU (including the Medical Device Single Audit Program), China's NMPA, South Korea's MFDS and Japan's PMDA — comparing inspection triggers, documentation expectations and how each authority handles findings. Case studies anchor the comparison in practice rather than a side-by-side reading of each regulation.

Who should attend

Regulatory affairs, quality assurance, compliance and operations professionals at device manufacturers selling into more than one of these markets, and anyone building or auditing an inspection-readiness program that has to hold up across jurisdictions. Comparing AI-specific device pathways instead? RAPS's AI Medical Device Regulations workshop covers FDA, EU MDR and China NMPA strategies for AI/ML-enabled devices, and RAPS's Cybersecurity Unauthorized workshop runs the same week on device cybersecurity submissions.