Regulatory Information
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: —
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: Yes
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/
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: —
Burundi
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: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes,
but not publically available
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
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: Yes,
but not publically available
Web site: —
Central African Republic
Authority responsible for implementing and enforcing regulations in your country: Yes
Name of principal institution: Direction des infrastructures sanitaires
Web site: —
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: —
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: —
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: —
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: —
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: —
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: —
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: —
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: —
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: —
Guinea-Bissau
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: —
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: —
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: —
Madagascar
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: Yes,
but not publically available
Web site: —
Malawi
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: Yes
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
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: Yes,
but not publically available
Web 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: —
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: —
Mozambique
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: Yes,
but not publically available
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: —
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: Yes,
but not publically available
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/
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: —
Sao Tome and Principe
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: —
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: —
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: —
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: —
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: —
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
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: —
Americas
Antigua and Barbuda
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: —
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: —
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: Yes,
but not publically available
Web site: —
Belize
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: —
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
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: —
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: —
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: —
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: —
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: —
Grenada
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: No
Web site:—
Technical specifications
Technical specifications to support procurement or donations: Yes, but not publically available
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
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: —
Haïti
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: Yes,
but not publically available
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: —
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: Yes,
but not publically available
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
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: —
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/
Bhutan
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
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: Yes,
but not publically available
Web site: —
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: —