Regulatory Information

VIA Global Health is committed to helping our buyers and partners contribute to better health outcomes, and helping our suppliers reach new markets where their products can make a difference. Although regulations, procurement, and donation guidelines vary significantly between countries, it is important to ensure good use of appropriate, affordable, and quality medical devices for health care delivery. The map and dropdown list below offer some information at the country level about regulation and procurement, and more information can be found in the World Health Organization’s Global Atlas of Medical Devices.

Africa

Americas

Asia

Europe

Middle East

Pacific

Africa

Algeria

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Ministère de la santé, de la Population et de la Réforme Hospitalière
Web site: www.sante.dz

Procurement
Policy or guideline: Yes
Web site: —
National level procurement: Yes
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Angola

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Direcção Nacional de Medicamentos e Equipamentos
Web site: http://dnme.co.ao/

Procurement
Policy or guideline: No
Web site: —
National level procurement: Yes
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Benin

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Direction Des Etablissements Hospitaliers
Web site: —

Botswana

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Procurement
Policy or guideline: Yes
Web site: http://www.ppadb.co.bw
National level procurement: Yes
Web site: —
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

Burkina Faso

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Direction générale de la pharmacie, du médicament et des laboratoires
Web site: http://www.dgpml.sante.gov.bf/

Burundi

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Cabo Verde

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: MINISTRY OF HEALTH
Web site: http://www.minsaude.gov.cv

Procurement
Policy or guideline: No
Web site: —
National level procurement: Yes
Web site: http://www.minsaude.gov.cv
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Cameroon

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: —
Web site: http://www.minsante.cm/site/?q=fr

Central African Republic

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Direction des infrastructures sanitaires
Web site: —

Chad

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Procurement
Policy or guideline: Yes
Web site: —
National level procurement: Yes
Web site: —
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Comoros

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Direction des Etablissements de soins Publics et privés
Web site: —

Congo

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Direction des laboratoires
Web site: —

Procurement
Policy or guideline: No
Web site: —
National level procurement: Yes
Web site: —
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Côte d'Ivoire

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Direction des infrastructures, de l’équipement, et de la maintenance
Web site: —

Procurement
Policy or guideline: Yes
Web site: —
National level procurement: No
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Democratic Republic of the Congo

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: La Direction des laboratoires de Santé /Ministère de la Santé
Web site: http://www.minisanterdc.cd/new/index.php

Procurement
Policy or guideline: No
Web site: —
National level procurement: No
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Eritrea

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Ministry of Health, Department of Regulatory services
Web site: —

Ethiopia

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Food, medical & health Administration and Control Authority
Web site: www.fmhaca.gov.et

Procurement
Policy or guideline: Yes
Web site: www.pfsa.gov.et
National level procurement: Yes
Web site: —
Donations
Policy or guideline: Yes
Web site:www.fmhaca.gov.et
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: www.pfsa.gov.et

Gabon

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Procurement
Policy or guideline: No
Web site: —
National level procurement: No
Web site: —
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Gambia

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Ghana

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Food and Drugs Authority Ghana
Web site: http://www.fdaghana.gov.gh/

Procurement
Policy or guideline: Yes
Web site: http://www.ppbghana.org/story_detail.asp?story_id=18
National level procurement: Yes
Web site: http://www.ghanahealthservice.org/division.
php?dsion=Supplies,Stores and Drugs Management&dd=32
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes
Web site: —

Guinea

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Division Equipement et Maintenance de la DNEHS
Web site: —

Guinea-Bissau

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Kenya

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Kenya Pharmacy and Poisons Board
Web site: http://pharmacyboardkenya.org/

Procurement
Policy or guideline: Yes
Web site: —
National level procurement: Yes
Web site: http://www.kemsa.co.ke/
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

Liberia

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Madagascar

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Malawi

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Mali

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Division établissements sanitaires et réglementation – Direction nationale de la Santé
Web site: pas de site

Mauritania

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Direction de la Medecine Hospitaliere (DMH)
Web site: www.sante.gov.mr/MSAS/Left/Presentatio_dmin07.htm

Procurement
Policy or guideline: Yes
Web site: http://www.sante.gov.mr/MSAS/
National level procurement: Yes
Web site: http:/ www.sante.gov.mr/MSAS/
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Mauritius

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Mozambique

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Namibia

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Directorate of Atomic Energy & Radiation Protection Authority
Web site: —

Procurement
Policy or guideline: —
Web site: http://www.healthnet.org.na
National level procurement: Yes
Web site: —
Donations
Policy or guideline: Yes
Web site:http://www.healthnet.org.na
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Niger

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Nigeria

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: National Agency for Food and Drug Administration and Control
Web site: http://www.nafdac.gov.ng/

Sao Tome and Principe

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Senegal

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Direction des Equipements et de la Maintenance(DEM)
Web site: http://www.sante.gouv.sn

Procurement
Policy or guideline: Yes
Web site: http://www.sante.gouv.sn
National level procurement: No
Web site: —
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes, but not publically available
Web site: —

Seychelles

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Togo

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Direction des Pharmacies Laboratoires et Equipements Techniques, Ministère de la Santé
et de la Population
Web site: —

Uganda

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: National Drug Authority
Web site: http://www.nda.or.ug

Procurement
Policy or guideline: Yes
Web site: —
National level procurement: Yes
Web site: http://www.health.go.ug
Donations
Policy or guideline: Yes
Web site:http://www.health.go.ug
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

Zambia

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Zambia Medicines Regulatory Authority (ZAMRA)
Web site: http://www.zamra.co.zm/

Procurement
Policy or guideline: Yes
Web site: http://www.mofnp.gov.zm/index.php?option=com_content&task=vi
ew&id=98&Itemid=120
National level procurement: Yes
Web site: http://www.tenderboard.gov.zm
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes
Web site: —

Zimbabwe

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Medical Devices Unit, Medicines Control Authority of Zimbabwe
Web site: http://www.mcaz.co.zw/index.php/component/content/article/40-uncategorised/86-medical-devices?highlight=YTozOntp
OjA7czo3OiJtZWRpY2FsIjtpOjE7czo3OiJkZXZpY2VzIjtpOjI7czoxNToibWVkaWNhbCBkZXZpY2VzIjt9

Americas

Antigua and Barbuda

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Argentina

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Dirección de Tecnología medica – dependiente de la Administracion de Medicamentos,
alimentos y tecnología médica.
Web site: http://www.anmat.gov.ar/productosmedicos.asp

Procurement
Policy or guideline: Yes
Web site: http://www.anmat.gov.ar/webanmat/productos_medicos/
recomendaciones_compraprod.medicos.asp
National level procurement: Yes
Web site: http://www.msal.gov.ar/
Donations
Policy or guideline: Yes
Web site:http://www.anmat.gov.ar/principal.asp
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Bahamas

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Procurement
Policy or guideline: No
Web site: —
National level procurement: Yes
Web site: http://www.phabahamas.org/
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Barbados

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Belize

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Bolivia (Plurinational State of)

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Unidad de Medicamentos y Tecnologia en Salud
Web site: http://www.sns.gov.bo/dinamed

Procurement
Policy or guideline: No
Web site: —
National level procurement: No
Web site: —
Donations
Policy or guideline: Yes
Web site:http://www.sns.gov.bo
Technical specifications
Technical specifications to support procurement or donations: Yes
Web site: http://www.sns.gob.bo

Brazil

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: ANVISA- Brazilian Health Surveillance Agency/ General Office of Medical Devices
Web site: http://www.anvisa.govl.br

Procurement
Policy or guideline: Yes
Web site: http://portalsaude.saude.gov.br/portalsaude/
National level procurement: Yes
Web site: http://portal.saude.gov.br/portal/saude/gestor/area.cfm?id_
area1504
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes
Web site: —

Canada

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Health Canada, Health Products and Food Branch, Therapeutic Products Directorate,
Medical Devices Bureau
Web site: http://www.hc-sc.gc.ca/dhp-mps/md-im/index-eng.php

Chile

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Instituto de Salud Pública de Chile
Web site: http://www.ispch.cl

Procurement
Policy or guideline: No
Web site: —
National level procurement: Yes
Web site: http://www.minsal.cl
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Colombia

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: INSTITUTO NACIONAL DE VIGILANCIA DE MEDICAMENTOS Y ALIMENTOS
Web site: http://www.invima.gov.co

Procurement
Policy or guideline: No
Web site: —
National level procurement: No
Web site: —
Donations
Policy or guideline: Yes
Web site:http://www.invima.gov.co
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Costa Rica

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Ministerio de Salud
Web site: http://www.ministeriodesalud.go.cr/index.php/menu-superior-empresas-ms

Procurement
Policy or guideline: No
Web site: —
National level procurement: Yes
Web site: http://ccss.sa.cr
Donations
Policy or guideline: Yes
Web site:http://www.ministeriodesalud.go.cr and http://www.portal.ccss.sa.cr
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Cuba

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Medicos (CECMED)
Web site: http://www.cecmed.cu/

Procurement
Policy or guideline: Yes
Web site: http://salud2015.sld.cu/proyecciones-para-el-2015.1pdf/nload
National level procurement: Yes
Web site: —
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

Dominica

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Dominican Republic

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Viceministerio de Garantia de la Calidad
Web site: http://www.sespas.gov.do

Procurement
Policy or guideline: Yes
Web site: —
National level procurement: Yes
Web site: http://www.sespas.gov.do
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Ecuador

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Coordinación Nacional de Desarrollo Estratégico Dirección de Inteligencia, Instituto
nacional de Higiene y Medicina Tropical
Web site: http://www.msp.gob.ec http://www.inh.gob.ec

Procurement
Policy or guideline: Yes
Web site: —
National level procurement: Yes
Web site: http://www.msp.gob.ec
Donations
Policy or guideline: Yes
Web site:http://www.msp.gob.ec/
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

El Salvador

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Director de Regulación y Legislación en Salud – Ministerio de Salud
Web site: —

Grenada

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Guatemala

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Departamento de Regulacion y Control de Productos Farmaceuticos y Afines
Web site: http://portal.mspas.gob.gt/nuevo_o_renovacion_de_la_inscripcion_sanitaria_de_productos_afines.html

Procurement
Policy or guideline: No
Web site: —
National level procurement: Yes
Web site: www.guatecompras.gob.gt
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Guyana

Authority responsible for implementing and enforcing regulations in your country: —
Name of principal institution: Food & Drug department
Web site: http://www.health.gov.gy/index.php/programmes/administration/food-drug-department

Haïti

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Honduras

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Dirección General de Regulación Sanitaria
Web site: http://www.dgrs.gob.hn

Procurement
Policy or guideline: Yes
Web site: http://www.honducompras.gob.hn/Info/Normativa.asp
National level procurement: Yes
Web site: —
Donations
Policy or guideline: Yes
Web site:http://www.dgrs.gob.hn
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Jamaica

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —

Mexico

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Comisón Federal para la protección contra riesgos sanitario (COFEPRIS)
Web site: http://www.cofepris.gob.mx

Procurement
Policy or guideline: Yes
Web site: http://www.cenetec.salud.gob.mx/interior/equipo_medico.html
National level procurement: No
Web site: —
Donations
Policy or guideline: Yes
Web site:http://www.cenetec.salud.gob.mx/interior/equipo_medico.html
Technical specifications
Technical specifications to support procurement or donations: Yes
Web site: http://www.cenetec.salud.gob.mx/interior/cet.html

Nicaragua

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Dirección General de Regulación Sanitaria
Web site: http://www.minsa.gob.ni

Procurement
Policy or guideline: No
Web site: —
National level procurement: Yes
Web site: http://www.minsa.gob.ni
Donations
Policy or guideline: Yes
Web site:http://www.minsa.gob.ni/regulacion/donaciones.html
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Panama

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Departamento de Investigacion y Desarrollo Tecnologico en Salud
Web site: http://www.minsa.gob.pa/minsa2008/final_newpage/dispositivos_medicos.htm
Procurement
Policy or guideline: Yes
Web site: http://190.34.154.88/WFichasTecnicasApp/
National level procurement: Yes
Web site: http://190.34.154.88/ProvServWebApp/
Donations
Policy or guideline: Yes
Web site:http://www.asamblea.gob.pa/APPS/LEGISPAN/PDF_
NORMAS/1990/1995/1995_114_1172.PDF
Technical specifications
Technical specifications to support procurement or donations: Yes
Web site: http://190.34.154.88/WFichasTecnicasApp/

Paraguay

Authority responsible for implementing and enforcing regulations in your country: —
Name of principal institution: Direccion de Viglancia Sanitaria del Ministerio de Salud Publica y Bienestar Social
(MSPyBS)
Web site: http://www.mspbs.gov.py/
Procurement
Policy or guideline: No
Web site: —
National level procurement: Yes
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Peru

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: DIGEMID
Web site: http://www.digemid.minsa.gob.pe
Procurement
Policy or guideline: Yes
Web site: http://www.digemid.minsa.gob.pe/dispositivos medicos
National level procurement: Yes
Web site: http/ www.dares.minsa.gob.pe
Donations
Policy or guideline: Yes
Web site:http://www.digemid.minsa.gob.pe/Main.asp?Seccion=469
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Saint Kitts and Nevis

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —
Procurement
Policy or guideline: No
Web site: —
National level procurement: Yes
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Saint Lucia

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: Not quite but we have a Bureau of standards who should be doing so
Web site: —
Procurement
Policy or guideline: No
Web site: —
National level procurement: No
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Saint Vincent and the Grenaines

Suriname

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —
Procurement
Policy or guideline: No
Web site: —
National level procurement: No
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Trinidad and Tobago

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Chemistry Food and Drug Division
Web site: http://www.health.gov.tt
Procurement
Policy or guideline: Yes
Web site: —
National level procurement: No
Web site: —
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes
Web site: —

United States of America

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health
(CDRH)
Web site: http://www.fda.gov/MedicalDevices/default.htm
Procurement
Policy or guideline: No
Web site: —
National level procurement: No
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Uruguay

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Ministerio de Salud Pública – Departamento de Evaluación de Tecnología
Web site: http://www.msp.gub.uy
Procurement
Policy or guideline: Yes
Web site: —
National level procurement: Yes
Web site: http://uca.mef.gub.uy/portal/web/guest/institucional AND
www.cocemi.com.uy/
Donations
Policy or guideline: Yes
Web site:http://www.msp.gub.uy
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Asia

Bangladesh

Directorate General of Drug Administration http://dgda.gov.bd/

http://www.cptu.gov.bd/default.aspx

Bhutan

Essential Medicine & Technology Division

www.health.gov.bt

India

Central Drugs Standard Control Organisation http://cdsco.nic.in

Indonesia

Directorate of Production and Distribution of Medical
Devices : http://www.binfar.depkes.go.id

Maldives

Medicine and Therapeutic Goods / Maldives Food and Drug Authority : http://www.health.gov.mv/]

Myanmar

Food and Drug Adminstration http://www.moh.gov.mm/

Nepal

Department of Health Services and Logistics management Division http://www.dohslmd.gov.np

Sri Lanka

Cosmetics, Devices and Drugs Authority http://www.health.gov.lk

Thailand

Food and Drug Administration http://www.fda.moph.go.th/

Timor-Leste Timor-Leste

N/A

Europe

Austria

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Austrian Medicines and Medical Devices Agency
Web site: http://www.basg.gv.at/en/medical-devices/
Procurement
Policy or guideline: Yes
Web site: http://www.hauptverband.at/
National level procurement: No
Web site: —
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

Serbia

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Agency for Drugs and Medical Devices
Web site: www.alims.gov.rs
Procurement
Policy or guideline: No
Web site: —
National level procurement: Yes
Web site: http://www.zdravlje.gov.rs/showpage.php?id=243
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

United Kingdom of Great Britain and Northern Ireland

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: The Medicines and Healthcare products Regulatory Agency (MHRA)
Web site: www.mhra.gov.uk
Procurement
Policy or guideline: Yes
Web site: http://nhscep.useconnect.co.uk AND http://www.nhsnss.org/pages/
divisions/national_procurement.php
National level procurement: Yes
Web site: http://www.supplychain.nhs.uk AND http://www.nhsnss.org
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes
Web site: http://nhscep.useconnect.co.uk

Middle East

Afganistan

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: General Directorate Pharmaceutical Affairs/MoPH
Web site: http://moph.gov.af/en
Procurement
Policy or guideline: No
Web site: —
National level procurement: No
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

Egypt

Authority responsible for implementing and enforcing regulations in your country: —
Name of principal institution: The Medical Device Safety Department (MDSD), within the Central Administration of
Pharmaceutical Affairs (CAPA), is a separate entity slated with monitoring the medical device market in Egypt.
Web site: http://www.eda.mohp.gov.eg/Services/Reg_MedDevice.aspx?Main=Services&Serviceid=2&Submain=serv8
Procurement
Policy or guideline: Yes
Web site: —
National level procurement: Yes
Web site: —
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes
Web site: —

Iraq

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: The State Company for Provision of Medicines and Medical Appliances (KIMADIA)
Web site: http://www.kimadia-iraq.com
Procurement
Policy or guideline: Yes
Web site: —
National level procurement: Yes
Web site: http://www.kimadia-iraq.com
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes, but not publically available
Web site: —

Jordan

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Jordan Food & Drug Adminstration
Web site: http://www.jfda.jo/en/default/
Procurement
Policy or guideline: Yes
Web site: http://gsd.gov.jo
National level procurement: No
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

Lebanon

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: National Council for Atomic Energy
Web site: http://www.cnrs.edu.lb/energycommission.html
Procurement
Policy or guideline: No
Web site: —
National level procurement: No
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

Libya

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Pharmacy Management, Equipment, Supplies and Medical Supplies Ministry of Health
Web site: http://www.health.gov.ly
Procurement
Policy or guideline: No
Web site: —
National level procurement: Yes
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Morocco

Oman

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Directorate General of Medical Supply
Web site: http://www.moh.gov.om/en/
Procurement
Policy or guideline: Yes
Web site: —
National level procurement: Yes
Web site: —
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

Pakistan

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Pakistan nuclear regulatory authority (PNRA) does partially for some medical devices,
otherwise no authority
Web site: http://www.pnra.org/
Procurement
Policy or guideline: Yes
Web site: http://www.ppra.org.pk
National level procurement: Yes
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes
Web site: http://www.sindhhealth.gov.pk/pprasindh.gov.pk

Qatar

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Medical Device Registration Unit, Pharmacy & Drug Control, Supreme Council of Health
Web site: http://www.sch.gov.qa/home-en
Procurement
Policy or guideline: Yes
Web site: —
National level procurement: Yes
Web site: http://www.hmc.org.qa/en/
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

Saudi Arabia

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Directorates of Supplies and Equipment; and Maintenance.
Web site: http://www.sfda.gov.sa/ar/Pages/default.aspx
Procurement
Policy or guideline: Yes
Web site: http://www.nupco.com
National level procurement: Yes
Web site: http://www.nupco.com
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes
Web site: —

Somalia

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: —
Web site: —
Procurement
Policy or guideline: No
Web site: —
National level procurement: No
Web site: —
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: —
Web site: —

Sudan

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: National Medicine and Poison Board
Web site: http://www.nmpb.gov.sd/
Procurement
Policy or guideline: No
Web site: —
National level procurement: Yes
Web site: —
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

Tunisia

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Ministry of health
Web site: http://www.santetunisie.rns.tn/index.html
Procurement
Policy or guideline: Yes
Web site: —
National level procurement: Yes
Web site: http://www.santetunisie.rns.tn/msp/msp.html
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

Yemen

Authority responsible for implementing and enforcing regulations in your country: No
Name of principal institution: Ministry of industry & The Supreme board for Drugs & Medical Appliance
Web site: www.sbd-ye.org www.moit.gov.ye
Procurement
Policy or guideline: Yes
Web site: www.htb.gov.ye
National level procurement: Yes
Web site: —
Donations
Policy or guideline: Yes
Web site:www.mophp-ye.org
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

Pacific

Japan

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Pharmaceutical and Medical Devices Agency ( PMDA), Ministry of Health. Labour and
Welfare
Web site: http://www.mhlw.go.jp/index.html and www.pmda.go.jp
Procurement
Policy or guideline: No
Web site: —
National level procurement: No
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —

Papua New Guinea

Authority responsible for implementing and enforcing regulations in your country: —
Name of principal institution: Pharmaceutical Services Standards Branch, Department of Health
Web site: http://www.health.gov.pg/pages/pharmaceutical.htm
Procurement
Policy or guideline: —
Web site: —
National level procurement: Yes
Web site: —
Donations
Policy or guideline: Yes
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
Web site: —

Singapore

Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: HEALTH SCIENCE AUTHORITY OF SINGAPORE
Web site: www.hsa.gov.sg
Procurement
Policy or guideline: No
Web site: —
National level procurement: No
Web site: —
Donations
Policy or guideline: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: No
Web site: —