Singapore (Hosted by HSA, Singapore)

Meeting no
29
Date
-
Location
Singapore

Jurisdictional Updates - Management Committee

Australia (TGA)
Brazil (ANVISA)
Canada (HC)
China (NMPA)
European Union (EC)
Japan (PMDA/MHLW)
Russia (MoH Russian Federation)
Singapore (HSA)
South Korea (MFDS)
Switzerland (Swissmedic)
United Kingdom (MHRA)
United States of America (USFDA)

Jurisdictional Updates - Official Observers

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

Jurisdictional Updates - Affiliate Members

Columbia (INVIMA)
El Salvador (SRS)
India (CDSCO)
Nigeria (NAFDAC)
Uzbekistan (CPPS)

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
Software as a Medical Device Working Group

Stakeholder Updates

APEC Regulatory Harmonization Steering Committee
DITTA and GMTA
Singapore Manufacturing Federation - Medical Technology Industry Group

Workshop Sessions - Day 1

Speakers from HSA, USFDA, WHO, GMTA&DITTA
Session 1 - The Reliance Playbook
Speakers from Swissmedic, ANMAT, DITTA, GMTA, Philips, MHRA, SRS
Session 2 - Reliance in the real world
Speakers from TGA, MDA, GMTA/DITTA, MTAA
Session 3 - Using alignment in product changes to strengthen reliance
Speakers from PMDA, ANVISA, BSI, USFDA, MFDS, HSA (IMDRF AET WG), GMTA/DITTA
Session 4 - Using MDSAP in Reliance