Argentine National Administration for Medicines, Food and Medical Technology
Administración Nacional de Medicamentos, Alimentos y Tecnologia Médica
COVID-19
Brazilian National Health Regulatory Authorities
Agência Nacional de Vigilância Sanitária
Gerência-Geral de Tecnologia de Produtos para Saúde (GGTPS)
ANVISA delegates to INMETRO the technical regulation of medical device conformity assessment.
COVID-19
Chilean National Institute of Public Health
Instituto de Salud Pública
Agencia Nacional de Dispositivos Médicos, Innovación y Desarrollo (ANDID)
COVID-19
Dirección de Regulación de Productos de Interés Sanitario
Registration of Products with Sanitary Interest
COVID-19
Colombian National Food and Drug Surveillance Institute
Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Medical Devices
COVID-19
Cuban Regulatory Authority for Medicines, Equipment and Medical Devices
Autoridad Reguladora de Medicamentos, Equipos y Dispositivos Médicos de la República de Cuba
Information for Registration of Equipment and IVDs
COVID-19
Ecuadorian National Authority for Regulation, Control and Sanitary Vigilance
Agencia Nacional de Regulación, Control y Vigilancia Sanitaria
COVID-19
Superintendence of Sanitary Regulation
Technical Regulation MedTech (Spanish only)
Reliance Policy (Spanish only)
Honduran Agency for Sanitary Regulation
Agencia de Regulación Sanitaria de Honduras
Registro Sanitario de Dispositivos Médicos
COVID-19
Mexican Federal Commission for the Protection against Sanitary Risk
Comisión Federal para la Protección contra Riesgos Sanitarios
COVID-19
Panamanian National Department of Medicines
Paraguayan Ministry of Public Health and Social Wellbeing
Ministerio de Salud Pública y Bienestar Social
Dirección General de Control de Profesionales, Establecimientos y Tecnologia de la Salud
COVID-19
Peruvian General Direction of Medicines, Supplies and Drugs
Dirección General de Medicamentos, Insumos y Drogas
Medical Devices
Dominican Ministry of Public Health and Social Assistance
Ministerio de Salud Pública y Asistencia Social
Dirección General de Medicamentos, Alimentos y Productos Sanitarios
COVID-19
The U.S. Food and Drug Administration (FDA) is the United States agency that regulates medical devices
The U.S. Food and Drug Administration (USFDA)
Center for Devices and Radiological Health (USFDA/CDRH)
USFDA/CDRH – COVID-19
Uruguayan Ministry of Public Health
Ministerio de Salud Pública
Departamento de Evaluación de Tecnologia
COVID-19
Venezuelan Autonomous Sanitary Controller Service
Servicio Autónomo de Contraloria Sanitaria
Dirección de Regulación y Control de Materiales, Equipos, Establecimientos y Profesionales de Salud
Instituto Nacional de Higiene Raafael Rangel
COVID-19
REGULATORY COALITION PRINCIPAL MEMBERS
