Brasilia, Brazil

Meeting no
9
Date
-
Location
Brasilia, Brazil

Jurisdictional updates

Australia
Brazil
Canada
China
EU
Japan
Russia
USA

Uncategorized

IMDRF Presentation - Update on AHWP Work
IMDRF Presentation - Updates of APEC
IMDRF Presentation - Regulatory Convergence on Medical Devices - An International Trade Approach
IMDRF Presentation - DITTA Contribution to IMDRF Stakeholder Forum
IMDRF Presentation - GMTA -Getting innovative medical technologies to patients - How IMDRF matters
IMDRF Presentation - PAHO - Update on the Regional Working Group
IMDRF Presentation - The Regulation of Medical Devices in Mercosur
IMDRF Presentation - Update on WHO work
IMDRF Presentation - Regulated Products Working Group
IMDRF Presentation - Adverse Event Terminology and Coding Working Group
IMDRF Presentation - Medical Device Single Audit Program (MDSAP) Pilot Update
IMDRF Presentation - National Competent Authority Report Exchange Programme
IMDRF Presentation - NCAR Performance / Statistics - January to 30th September 2015
IMDRF Presentation - Integrating Device Registries and Innovative Tools for Medical Device Evaluation
IMDRF Presentation - Software as a Medical Device (SaMD)Application of Clinical Evaluation
IMDRF Presentation - IMDRF ToC Pilot

Working group updates

Good Regulatory Review Practices Working Group Update
Medical Device Single Audit Program Working Group Update

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)