Dispositifs medicaux - World Health Organization€¦ · Medicamentos y Alimentos (INVIMA) Decree...

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Séminaire sur les Politiques Pharmaceutiques à l'attention des experts francophones . 18-04-013 Dispositifs medicaux Adriana Velazquez Berumen: Coordinatriz Dispositifs Medicaux Département des Médicaments Essentiels et des Produits de Santé

Transcript of Dispositifs medicaux - World Health Organization€¦ · Medicamentos y Alimentos (INVIMA) Decree...

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Séminaire sur les Politiques Pharmaceutiques à l'attention des

experts francophones . 18-04-013

Dispositifs medicaux

Adriana Velazquez Berumen: Coordinatriz Dispositifs Medicaux

Département des Médicaments Essentiels et des Produits de Santé

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Dispositifs medicaux sont essentiels

XXI C. beaucoup manque les plus essentiels

Qu’ est ce que vous allez faire?

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Title Link to PDF file

World Health Assembly Resolution:

WHA60.29 Technologies Sanitaires

http://www.who.int/entity/medical_devices/policies/re

solution_wha60_r29-fr.pdf

DISPOSITIFS MÉDICAUX : COMMENT

RÉSOUDRE

l’inadéquation ?

http://whqlibdoc.who.int/publications/2012/97892425

64044_fre.pdf

Développement de politiques relatives aux

dispositifs médicaux

http://whqlibdoc.who.int/publications/2012/97892425

01636_fre.pdf

Évaluation des technologies de la santé :

dispositifs médicaux

http://whqlibdoc.who.int/publications/2012/97892425

01360_fre.pdf

Evaluation des besoins en

dispositifs médicaux

http://whqlibdoc.who.int/publications/2012/97892425

01384_fre.pdf

Processus d’acquisition :

guide pratique

http://whqlibdoc.who.int/publications/2012/97892425

01377_fre.pdf

Dons de dispositifs médicaux :

considérations relatives à leur

demande et à leur attribution

http://whqlibdoc.who.int/publications/2012/97892425

01407_fre.pdf

Introduction à la gestion du parc des

équipements médicaux

http://whqlibdoc.who.int/publications/2012/97892425

01391_fre.pdf

Programme de maintenance

des équipements médicaux :

présentation générale

http://whqlibdoc.who.int/publications/2012/97892425

01537_fre.pdf

Système de gestion de

maintenance assistée par

ordinateur

http://whqlibdoc.who.int/publications/2012/97892425

01414_fre.pdf

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Definitions

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Differences entre dispositifs medicaux

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Differences entre dispositifs medicaux et

produits pharmaceutiques

Diversité

taille,complexite, utilisation, plus de 20,000 types

Duree d’utilisation

tres variable, quelques minutes jusqu’a dizaines de annees.

Mode d’action

effects locaux et physiques sur l’organism, pas systemiques

ou pharmacologiques.

Utilisation

besoin de formation et support technique, maintenance

Reglementation

selon le risque associe a leur utilisation.

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5 a: accesibilite, adequation, disponibilite,

accesibilite economique, acceptabilite

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Serie technique de la OMS sur les dispositifs

medicaux

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Politique et plan sanitaire national pour les

besoins de la population

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Pays qui ont une politique de technologies de la Sante

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Pays disposant d’une entite pour la mise en ouvre de la politique relative aux technologies de la Sante

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Pays disposant d’une liste nationale de dispositifs medicaux approuves pour l’achat et le remboursement

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Evaluation de technologies de la sante

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Evaluations de besoins de dispositifs

medicaux

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OMS information du pays example: Canada Health Canada Legislation (2011) &

Regulations (2008)

Safety Alerts Adverse Reaction and

Medical Device

Problem Reporting

Adverse

Reaction

Database

Health Canada

Address Locator 0900C2

Ottawa, Ontario

K1A 0K9

Email: [email protected]

Telephone: 613-957-2991

Chile Instituto de Salud Púlica Legislation (2009)

Regulations (1999)

Current Regulations

(2011)

Safety Alerts Mesa Central

(56-2) 5755 101 Information

(56-2) 5755 201 Contact

Colombia Instituto Nacional de

Vigilancia de

Medicamentos y

Alimentos (INVIMA)

Decree (2009)

Resolution (2010)

Safety Alerts Health reporting

forms

Headquarters

Carrera 68D # 17 - 11/21

Bogota, Colombia

Switch Telephone: 2948700

Costa Rica Ministerio de Salud Regulations

Other regulations

Safety Alerts Adverse reaction

reporting

Ministry of Health - 2009,

Street 16, Avenues 6 and 8 -

San Jose, Costa Rica, Phone:

(506) 2223-0333

Cuba Centro Para el Control

Estatal de

Medicamentos, Equipos

y Dispositivos Médicos

(CECMED)

Regulations Safety Alerts [email protected]

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Information du pays

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www.who.int/ medical devices/ en

Merci!!!

OMS

Publications du Pays

OMS publications

(2008-2012)