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

Tuesday, 27 October 2026

1. 10:00 – 10:05

   Welcome and Agenda

   sensorsOnline

   Opening remarks and introduction to the global medical device inspection workshop.

2. 10:05 – 10:25

   Global Inspection Framework: What Is Common vs. What Differs

   sensorsOnline

   Comparison of global medical device inspection frameworks and their common regulatory expectations.

3. 10:25 – 10:55

   Japan PMDA GMP: Key Regulations, MAH, GMP Inspections, Trends and Key Findings

   sensorsOnline

   Japanese medical device manufacturing inspection requirements and practical industry experiences.

4. 10:55 – 11:25

   Korea MFDS GMP/Inspections

   sensorsOnline

   Key regulations, inspection focus areas, evidence expectations and effective remediation.

5. 11:25 – 11:35

   Break

   sensorsOnline
6. 11:35 – 12:05

   China NMPA GMP/Inspections

   sensorsOnline

   New GMP requirements, inspection key points, common pitfalls, response strategy and effective remediation.

7. 12:05 – 12:35

   MDSAP and EU MDR Third-Party Audit Expectations

   sensorsOnline

   Evidence requirements, nonconformities and follow-up activities under MDSAP and EU MDR audits.

8. 12:34 – 13:05

   US FDA Inspections: Current Trends and QMSR Implications

   sensorsOnline

   Inspection readiness under QMSR, investigator focus, responses and remediation.

9. 13:05 – 13:45

   Moderated Panel: Global Inspection Readiness — What Really Matters in Practice

   sensorsOnline

   Industry panel addressing practical challenges and strategies for successful global inspections.

10. 13:45 – 14:00

    Conclusion and Q&A

    sensorsOnline

    Closing discussion and audience questions.