A whole slew of regulatory bodies from across the world

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

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