Singapore (Hosted by HSA)

Meeting no
30
Date
-
Location
Singapore

Workshop Sessions - Day 1

Scene Setting - Global regulatory landscape for digital health technology
Session 1- Software Characterization and Risk Categorization – From Guidance to Practice
Session 2 - AI Governance and Machine Learning Practices (GMLP)
Session 3 - Predetermined Change Control Plans (PCCP)

Jurisdictional Updates - Management Committee

Australia (TGA)
Brazil (ANVISA)
Canada (Health Canada)
China (NMPA)
European Union (European Commission)
Japan (PMDA)
Russia (MoH)
Switzerland (Swissmedic)
Singapore (HSA)
United Kingdom (MHRA)
South Korea (MFDS)
United States of America (FDA)

Jurisdictional Updates - Official Observers

Argentina (ANMAT)
Saudi Arabia (SFDA)
The World Health Organisation (WHO)

Jurisdictional Updates - Affiliate Members

Cuba (CECMED)
Paraguay (DINAVISA)
Tanzania (TMDA)
Israel (MTIIR)

Jurisdictional Updates - Regional Health Initiatives

Working Group Updates

Working Group Updates - Consolidated

Stakeholder Updates

DITTA and GMTA
IMDRF Industry Group
Singapore Manufacturing Federation - Medical Technology Industry Group