Yekaterinburg, Russia

Meeting no
16
Date
-
Location
Yekaterinburg, Russia

Uncategorized

Presentation - Medical AI in Skolkovo Global market launch for Russian startups
Presentation - Perspectives and Regulatory Considerations for AI based Medical Devices
Presentation - World Health Organization plans for using big data and Artificial Intelligence to achieving universal health coverage
Presentation - Regulatory framework on medical devices using AI technology in Russia
Presentation - The Development of policy measures on medical devices using AI technology in Japan
Presentation - Overview of AI Standardization Activities
Presentation - Experience of using products based on artificial intelligence in the Yamal Healthcare
Presentation - Experience in testing and comparing different solution based on Artificial Intelligence for the Moscow health service
Presentation - Preparation and conduct clinical trials for an Artificial Intelligence-based clinical decision support system
Presentation - How Industry can cope with challenges
Presentation - Industry Responsibility and Liability
Presentation - Introduction to review points for decision - making medical device software using deep learning technology
Presentation - Regulatory challenges for AI - a European RA perspective
Presentation - Industry overview on regulatory challenges
Presentation - Applying Advanced Technology in Clinical Practice
IMDRF Presentation - Stakeholder - Ministry of industry and trade of Russia
IMDRF Presentation - Stakeholder - WHO Update
IMDRF Presentation - Stakeholder - APEC Update
IMDRF Presentation - Stakeholder - AHWP Update
IMDRF Presentation - Stakeholder - PAHO Update
IMDRF Presentation - Stakeholder - DITTA Update
IMDRF Presentation - Stakeholder - GMTA Update
IMDRF Presentation - Stakeholder - IAMT Update
IMDRF Presentation - Stakeholder - IMEDA Update
IMDRF Presentation - Stakeholder - Abbott laboratories Update

Jurisdictional updates

Australia
Jurisdictional Update
Canada
China
EU
Japan
Russia
Singapore
South Korea
USA

Working group updates

Regulated Products Submission
Adverse Event Terminology and Coding
Good Regulatory Review Practices
Standarts Working Group
Personalized Medical Devices
Medical Device Clinical Evaluation
Medical Device Cybersecurity
Principles on In Vitro Diagnostic Medical Devices Classification

Member sites

Regional harmonization initiatives

APEC LSIF Regulatory Harmonization Steering Committee

Global Harmonization Working Party (GHWP)

Pan American Health Organization (PAHO)

African Medical Devices Forum (AMDF)

Official observers

Argentina, National Administration of Drugs, Food and Medical Devices

The World Health Organization (WHO)

Saudi Arabia, Saudi Food and Drug Authority

Switzerland, Swissmedic

Affiliate members

Botswana - Botswana Medicines Regulatory Authority (BoMRA)

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

Costa Rica - Ministry of Health

Cuba - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (CECMED)

Dominican Republic - General Directorate of Medicines, Food and Health Products (DIGEMAPS)

Egypt - Egyptian Drug Authority  (EDA)

El Salvador - Sanitary Regulation Superintendency (SRS)

Ethiopia - Ethiopian Food and Drug Authority (EFDA)

India - Central Drugs Standard Control Organization (CDSCO)

Israel - The Medical Technology, Health Information, Innovation and Research Directorate (MTIIR)

Affiliates

 

Jordan - Jordan Food and Drug Administration (JFDA)

Kenya - Pharmacy and Poisons Board (PPB)

Mexico - Federal Commission for Protection from Sanitary Risks (COFEPRIS)

Montenegro - Institute for Medicine and Medical Devices of Montenegro (CINMED)

Nigeria - National Agency for Food and Drug Administration Control (NAFDAC)

Oman - Drug Safety Center, Medical Device Control Department (DSC)

Paraguay - National Health Surveillance (DINAVISA)

Peru - General Directorate of Medicines, Supplies and Drugs (DIGEMID)

South Africa - South African Health Products Regulatory Authority (SAHPRA)

Tanzania - Tanzania Medicines and Medical Devices Authority (TMDA)

Zimbabwe - Medicines Control Authority (MCAZ)