Medical Device Regulatory Agencies

ANMAT
Argentine National Administration for Medicines, Foods and Medical Technology
Administración Nacional de Medicamentos, Alimentos y Tecnología Médica
COVID-19

ANVISA
Brazilian National Health Regulatory Agency 
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

Health Canada
Health Canada
Medical Devices
COVID-19

ISP
Chilean National Institute of Public Health
Instituto de Salud Publica
Subdepartamento de Dispositivos Médicos
COVID-19

Costa Rican Ministry of Health
Ministerio de Salud de Costa Rica
Dirección de Regulación de Productos de Interés Sanitario
Registration of Products with Sanitary Interest
COVID-19

INVIMA
Colombian National Food and Drug Surveillance Institute
Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Medical Devices
COVID-19

CECMED
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

ARCSA
Ecuadorian National Agency for Regulation, Control and Sanitary Vigilance
Agencia Nacional de Regulación, Control y Vigilancia Sanitaria
COVID-19

DNM
Salvadorian National Department of Medicines
Dirección Nacional de Medicamentos

ARSA
Honduran Agency for Sanitary Regulation
Agencia de Regulación Sanitaria de Honduras
Registro Sanitario de Dispositivos Médicos
COVID-19

COFEPRIS
Mexican Federal Commission for the Protection against Sanitary Risk
Comisión Federal para la Protección contra Riesgos Sanitarios
COVID-19

DIGEMID
Peruvian General Direction of Medicines, Supplies and Drugs
Direccion General de Medicamentos, Insumos y Drogas
Medical Devices

DIGEMAPS
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

USFDA
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

MSP
Uruguayan Ministry of Public Health
Ministerio de Salud Pública
Departamento de Evaluación de Tecnología
COVID-19

SACS
Venezuelan Autonomous Sanitary Comptroller Service 
Servicio Autónomo de Contraloría Sanitaria
Dirección de Regulación y Control de Materiales, Equipos, Establecimientos y Profesionales de Salud
Instituto Nacional de Higiene Rafael Rangel
COVID-19