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

World Health Organization (WHO)

Swissmedic

 

Affiliate members

 

Chile - Public Health Institute of Chile (ISP)

Chinese Taipei Taiwan Food and Drug Administration (TFDA)

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

Egypt - Egyptian Drug Authority  (EDA)

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

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

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

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