Sapporo, Japan (Hosted by Japan)

Meeting no
28
Date
-
Location
Sapporo, Japan

Jurisdictional Updates - Management Committee

Australia (MC Member)
Brazil (MC Member)
Canada (MC Member)
China (MC Member)
European Union (MC Member)
Japan (MC Member)
South Korea (MC Member)
Russia (MC Member)
Singapore (MC Member)
Switzerland (MC Member)
United Kingdom (MC Member)
USA (MC Member)

Jurisdictional Updates - Official Observers

Argentina (Official Observer)
Saudi Arabia (Official Observer)
The World Health Organization (Official Observer)

Jurisdictional Updates - Affiliate Members

Egypt (EDA)
Malaysia (MDA)
Oman (MOH)

Working Group Updates

Adverse Event Terminology Working Group
Artificial Intelligence Machine Learning-enabled Working Group
Clinical Evidence for IVD Working Group
Good Regulatory Review Practices Working Group
Personalized Medical Devices Working Group
Quality Management Systems Working Group
Regulated Product Submission Working Group
Software as a Medical Device Working Group

Stakeholder Updates

AMDF (Regional Harmonization Initiative)
APEC (Regional Harmonization Initiative)
PAHO (Regional Harmonization Initiative)
UDI Australia (TGA)
UDI Brazil (ANVISA)
UDI Japan (MHLA)
UDI Saudi Arabia (SFDA)
UDI Industry (BD)

Joint IMDRF/Industry Workshop - Modernizing Conformity Assessment Through Innovative Processes

Session 1: Conformity Assessment for Medical Devices and IVDs based on IMDRF/GHTF principles (HSA)
Session 2: Classification approaches to foster convergence: Mapping challenges and considerations
Session 4: Emerging best practices in evidence development: Leveraging advances in real-world evidence (RWE) and other innovative evidence types to fill data gaps created by classification differences