- Afghanistan – General Directorate Pharmaceutical Affairs, Ministry of Public Health
- Albania – National Agency for Drugs and Medical Devices (AKBPM)
- Algeria – Direction de la Pharmacie et du Medicament, Ministere de la Sante, de la Population et de la Reforme
- Andorra – No regulatory agency
- Angola – Direcção Nacional de Medicamentos e Equipamentos
- Antigua and Barbuda – No regulatory agency
- Argentina – Direccion de Tecnologia Medica, Administracion National de Medicamentos, Alimentos y Tecnologia Médico (ANMAT)
- Armenia – No regulatory agency
- Australia – Australian Therapeutic Goods Administration (TGA)
- Austria – Austrian Medicines and Medical Devices Agency
- Azerbaijan – CSEEA Analytical Expertise Centre
- Bahamas – No regulatory agency
- Bahrain – Pharmaceutical Product Regulatory Office, National Health Regulatory Authority
- Bangladesh – Directorate General of Drug Administration
- Barbados – No regulatory agency
- Belarus – Department of Medical Equipment, Logistical Support, and Construction, Ministry of Health
- Belgium – Health Products Division, Agence Fédérale des Médicaments et des Produits de Santé (AFMPS)
- Belize – No regulatory agency
- Benin – No regulatory agency
- Bhutan – Drug Regulatory Authority
- Bolivia – Unidad de Medicamentos y Technologia en Salud
- Bosnia and Herzegovina – Agency for Medicinal Products and Medical Devices
- Botswana – No regulatory agency
- Brazil – Brazilian Health Surveillance Agency
- Brunei – No regulatory agency
- Bulgaria – Bulgarian Drug Agency (BDA)
- Burkina Faso – Direction générale de la pharmacie, du médicament et des laboratoires
- Burundi – Department of Pharmacy, Medicines and Laboratories (DPML), Ministry of Health
- Cambodia – No regulatory agency
- Cameroon – Direction de la Pharmacie, du Medicament et de Laboratoires.
- Canada – Health Canada, Health Products and Food Branch, Therapeutic Products Directorate, Medical Devices Bureau
- Cape Verde – Agency of Regulation and Supervision of Pharmaceutical and Food Products (ARFA)
- Central African Republic – No regulatory agency
- Chad – No known regulatory agency
- Chile – Subdepartmento de Dispositivos Médicos, Instituto de Salud Publica
- China – China Food and Drug Administration
- Colombia – National Food and Drug Surveillance Institute (Instituto Nacional de Vigilancia de Medicamentos y Alimentos) (INVIMA)
- Comoros – No regulatory agency
- Congo – No regulatory agency
- Cook Islands – No regulatory agency
- Costa Rica – Ministerio de Salud
- Cote d’Ivoire – No regulatory agency
- Croatia – Agency for Medicinal Products and Medical Devices (HALMED)
- Cuba – Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Medicos (CECMED)
- Cyprus – Cyprus Medical Devices Competent Authority
- Czech Republic – Ministry of Health – State Institute for Drug Control
- Democratic Republic of the Congo – La Direction des laboratoires de Santé /Ministère de la Santé
- Denmark – Danish Medicines Agency
- Djibouti – No regulatory agency
- Dominica – No regulatory agency
- Dominican Republic – No regulatory agency
- East Timor – No regulatory agency
- Ecuador – Agencia Nacional de Regulación, Control y Vigilancia Sanitaria
- Egypt – Medical Device Department, Egyptian Drug Authority
- El Salvador – Direccion Nacional de Medicamentos
- Equatorial Guinea – No regulatory agency
- Eritrea – No regulatory agency
- Estonia – Medical Devices Department, Estonian Health Board
- Ethiopia – Food, Medicine and Health Care Administration and Control Authority of Ethiopia
- Fiji – No device regulations, but Fiji has a donation policy for medical equipment in place.
- Finland – National Supervisory Authority for Welfare and Health (Valvira)
- France – Agence nationale de sécurité du médicament et des produits de santé
- Gabon – The Direction du Médicament et de la Pharmacie has no responsibilities for regulation of medical devices.
- Gambia – No regulatory agency
- Georgia – Department of Pharmaceuticals of State Regulatory Agency for Medical Activities
- Germany – Federal Institute for Drugs and medical Devices (BfArM)
- Ghana – Medical Devices Department (MDD), Food and Drugs Authority Ghana
- Greece – National Organization for Medicines
- Grenada – No regulatory agency
- Guatemala – Departmento de Regulacion y Control de Productos Farmaceuticos y Afines
- Guinea – No regulatory agency
- Guinea-Bissau – No regulatory agency
- Guyana – Food & Drug department
- Haïti – No regulatory agency
- Honduras – Direccion General de Regulacion Sanitaria
- Hungary – Department for Medical Devices, National Institute of Pharmacy
- Iceland – Icelandic Medicines Agency
- India – Central Drugs Standard Control Organisation
- Indonesia – Directorate General of Pharmaceutical and Medical Devices, The Ministry of Health of the Republic of Indonesia
- Iran – Food and Drug Administration of Iran
- Iraq – The State Company for Provision of Medicines and Medical Appliances (KIMADIA) – oversees imported medical devices
- Ireland – Health Products Regulatory Authority
- Israel – Medical Device Department, Ministry of Health
- Italy – Ministry of Health
- Jamaica – Standards & Regulations Division
- Japan – Pharmaceuticals and Devices Agency (PMDA)
- Jordan – Medical Devices & Supplies Directorate, Jordan Food and Drug Administration
- Kazakhstan – National Centre for Medicines, Medical Devices, and Medical Equipment Expertise
- Kenya – Kenya Pharmacy and Poisons Board
- Kiribati – Medical Equipment Management Committee
- Kuwait – No regulatory authority, but relies instead on importation and registration decisions by the Gulf Cooperation Council
- Kyrgyzstan – State Department of Medicine Provision and Medical Equipment under the Ministry of Health of the Kyrgyz Republic
- Laos – Food and Drug Department, Ministry of Health
- Latvia – State Agencies of Medicines
- Lebanon – Ministry of Public Health
- Lesotho – No regulatory agency
- Liberia – No regulatory agency
- Libya – Pharmacy Management, Equipment, Supplies and Medical Supplies, Ministry of Health
- Lithuania – State Health Care Accreditation Agency, Ministry of Health
- Luxembourg – Ministère de la Santé
- Macedonia – Bureau of Drugs, Ministry of Health
- Madagascar – L’Agence du Médicament de Madagascar
- Malawi – No regulatory agency
- Malaysia – Medical Device Authority, Ministry of Health Malaysia
- Maldives – Maldives Food and Drug Authority
- Mali – No regulatory agency
- Malta – Malta Competition and ConsumerAffairs Authority (MCCAA)
- Marshall Islands – No regulatory agency
- Mauritania – No regulatory agency
- Mauritius – No regulatory agency
- México – Comision Federal para la Proteccion contra Riegos Sanitarios (COFEPRIS) Secretaria de Salud
- Micronesia (Federated States of) – No regulatory agency
- Moldova – Medicines and Medical Devices Agency (Agentia Medicamentului si Dispozitivelor Medical (ANDM))
- Monaco – Direction de l`Action Sanitaire et Sociale
- Mongolia – No known regulatory agency
- Montenegro – Agency for Medicines and Medical Devices of Montenegro
- Morocco – La commission nationale consultative des dispositifs médicaux’ Loi No 84-12, art 36.
- Mozambique – No regulatory agency
- Myanmar – Food and Drug Administration, Myanmar
- Namibia – Namibia Medicines Regulatory Council
- Nauru – No regulatory agency
- Nepal – No regulatory agency
- Netherlands – Dutch Healthcare Inspectorate
- New Zealand – Medicines and Medical Device Safety Authority (MedSafe)
- Nicaragua – Direccion General de Regulacion Sanitaria, Ministerio de Salud (MINSA)
- Niger – No regulatory agency
- Nigeria – National Agency for Food and Drug Administration and Control (NAFDAC)
- Niue – No regulatory agency
- North Korea – No regulatory agency
- Norway – Norwegian Directorate of Health
- Oman – Directorate General of Medical Supply, Ministry of Health
- Pakistan – Medical Devices and Medicated Cosmetics Division, Drug Regulatory Authority of Pakistan
- Palau – No regulatory agency
- Panama – La Dirección Nacional de Farmacia y Drogas del Ministerio de Salud de Panamá
- Papua New Guinea – The Pharmaceutical Services Standards Branch is currently registering medical products, including medical devices, provisionally now according to its website.
- Paraguay – Direccion de Viglancia Sanitaria del Ministerio de Salud Publica y Bienestar Social (MSPyBS)
- Perú – Direccion General de Medicamentos, Insumos y Drogas (DIGEMED)
- Philippines – Bureau of Health Devices and Technology (BHDT), Department of Health
- Poland – The Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
- Portugal – National Authority of Medicnes and Health Products (INFARMEDC, IP)
- Qatar – Medical Device Registration Unit, Pharmacy & Drug Control, Supreme Council of Health
- Romania – National Agency for Medicines and Medical Devices
- Russia – Federal Service on Surveillance (Roszdravnadzor)
- Rwanda – No regulatory agency
- Saint Kitts and Nevis – No regulatory agency
- Saint Lucia – No regulatory agency
- Saint Vincent and the Grenadines – No regulatory agency
- Samoa – Samoa has a Medical Equipment Management Policy and Medical Equipment Donation Policy.
- San Marino – No regulatory agency
- Sao Tome and Principe – No regulatory agency
- Saudi Arabia – Medical Device Sector, Saudi Food & Drug Authority (SFDA)
- Senegal – La Direction des Infrastructures, des Equipmement et de la Maintenance
- Serbia – Medicines and Medical Devices Agency (ALIMS)
- Seychelles – No regulatory agency
- Sierra Leone – The Pharmacy Board of Sierra Leone, Ministry of Health and Sanitation.
- Singapore – Medical Device Branch, Health Sciences Authority
- Slovakia – State Institute for Drug Control
- Slovenia – Agency for Medicinal Products and Medical Devices of the Republic of Slovenia
- Solomon Islands – No regulatory agency
- Somalia – No regulatory agency
- South Africa – Medicines Control Council (MCC)
- South Korea – Korean Food and Drug Administration (KFDA)
- South Sudan – No regulatory agency
- Spain – Agencia Española de Medicamentos y Productos Sanitarios
- Sri Lanka – Cosmetics, Devices & Drugs Regulatory Authority
- Sudan – National Medicines and Poisons Board
- Suriname – No regulatory agency
- Swaziland – No regulatory agency
- Sweden – Medical Products Agency (MPA)
- Switzerland – Swiss Agency for Therapeutic Products, Swissmedic
- Syria – No regulatory agency
- Tajikistan – No regulatory agency
- Tanzania – Tanzania Food and Drugs Authority (as of December 10, 2018, according to the World Health Organization, “Tanzania is the first confirmed country in Africa to achieve a well-functioning, regulatory system for medical products“)
- Thailand – Food and Drug Administration, Medical Device Control Division
- Togo – Direction des Pharmacies Laboratoires et Equipements Techniques Ministère de la Santé et de la Population
- Tonga – No regulatory agency
- Trinidad and Tobago – Chemistry, Food, and Drugs Division
- Tunisia – Ministry of Health, but no specific responsibilities asigned for regulation of medical devices
- Turkey – Turkey Medicines and Medical Devices Agency, Ministry of Health
- Turkmenistan – No regulatory agency
- Tuvalu – No regulatory agency
- Uganda – National Drug Authority (NDA)
- Ukraine – State Administration of Ukraine on Medicinal Products (SAUMP)
- United Arab Emirates – Ministry of Health
- United Kingdom – Medicines & Healthcare products Regulatory Agency (MHRA)
- United States of America – Center for Devices and Radiological Health (CDRH), Food and Drugs Administration (FDA)
- Uruguay – Ministerio de Salud Publica
- Uzbekistan – Ministry of Health, General Directorate for the quality control of medicines and medical equipment (GDQC).
- Vanuatu – No regulatory agency
- Venezuela – Servicio Autonomo de Contraloría Sanitaria (SACS)
- Vietnam – Department of Medical Equipment and Health Works
- Yemen – The Supreme board for Drugs & Medical Appliances
- Zambia – Zambia Medicines Regulatory Authority (ZAMRA)
- Zimbabwe – Medical Devices Unit, Medicines Control Authority of Zimbabwe
Contact

Barry Belmont
A Lecturer
Department of Biomedical Engineering
(734) 647-8638
2130 LBME