Brazil

Meeting no
10
Date
-
Location
Brazil

Stakeholder updates

IMDRF Presentation - 5 years of IMDRF
IMDRF Presentation - Brazilian System for Conformity Assessment - Brazil
IMDRF Presentation - ISO 14155 2011 Clinical investigation of MD for human subjects - Japan
IMDRF Presentation - MDSAP - Pilot update - ANVISA Brazil
IMDRF Presentation - Good Regulatory Practice - experience and challenges - ANVISA Brazil
IMDRF Presentation - RPS - Pilot ToC industry feedback and impression - Johnson & Johnson
IMDRF Presentation - Stakeholder - AHWP update
IMDRF Presentation - Stakeholder - DITTA update
IMDRF Presentation - Stakeholder - GMTA update
IMDRF Presentation - Stakeholder - PAHO update
IMDRF Presentation - Stakeholder - WHO update
IMDRF Presentation - UDI Implementation update - USA

Jurisdictional updates

Brazil
Canada
China
EU
Japan
Russia
USA

Working group updates

Adverse Event Terminology
Good Regulatory Review Practices
Improving Quality of International Standards
Medical Device Patient Registries
Regulated Product Submission (RPS)
Software as a Medical Device (SaMD) Clinical Evaluation
NCAR

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)