Ottawa, Canada

Meeting no
12
Date
-
Location
Ottawa, Canada

Uncategorized

IMDRF Open Stakeholder Day
Presentations from DITTA workshops 18 September
IMDRF Stakeholder Forum Agenda - Wednesday 20 September 2017
IMDRF Presentation - New Work Item Proposal - Definitions for Patient-Specific, Customized and Custom-made Medical Devices
IMDRF Presentation - Real World Evidence panel - CADTH and Clinician
IMDRF Presentation - Real World Evidence panel - Industry
IMDRF Presentation - Real World Evidence panel - NESTcc overview
IMDRF Presentation - Stakeholder - AHWP update
IMDRF Presentation - Stakeholder - APEC update
IMDRF Presentation - Stakeholder - DITTA update
IMDRF Presentation - Stakeholder - GMTA update
IMDRF Presentation - Stakeholder - PAHO update
IMDRF Presentation - Stakeholder - WHO update

Jurisdictional updates

Australia
ANVISA
Canada
China
EU
Russia
Japan
Singapore
US

Working group updates

Adverse Events Terminology
Good Regulatory Review Practices
NCAR
Registries
Regulated Product Submission
Software as a Medical Device (SaMD)
Standards

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)