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dc.contributor.author
Rey Ares, Lucila
dc.contributor.author
Hernández Vásquez, Akram
dc.contributor.author
Garay, Osvaldo Ulises
dc.contributor.author
Pichón-Riviere, Andrés
dc.contributor.author
García Martí, Sebastián
dc.contributor.author
Gilardino, Ramiro
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Cabra, Hermilio Arturo
dc.contributor.author
Augustovski, Federico Ariel
dc.date.available
2018-06-05T18:10:28Z
dc.date.issued
2016-11
dc.identifier.citation
Rey Ares, Lucila; Hernández Vásquez, Akram; Garay, Osvaldo Ulises; Pichón-Riviere, Andrés; García Martí, Sebastián; et al.; Medical devices: from licensing to coverage. highlights from Argentina, Brazil, Colombia and Mexico; Expert Reviews; Expert Review of Medical Devices; 13; 11; 11-2016; 1053-1065
dc.identifier.issn
1743-4440
dc.identifier.uri
http://hdl.handle.net/11336/47340
dc.description.abstract
Objectives: To assess, describe and compare the requirements and pathwaysof medical devices from licensing to coverage in four Latin American countries(LAC) health systems. Methods: We conducted a literature search (February 2015)on Pubmed, Lilacs and Value in Health Regional Issues journal. We also searchedspecific websites of Health Technology Assessment (HTA) and regulatory agencies,ministries of health and health agencies; and a performed generic Internet search.We included all publications describing aspects related to regulation, coverage,medical technology innovation, and HTA and Economic Evaluation (EE) guidelines.We additionally interviewed key informants from all countries to gather informationrelated to the aforementioned processes. We present here the literature searchresults. Results: We included 60 studies out of 2190. Five percent of the publicationsanalyzed the four countries jointly, 75% were from Brazil, 8.3% from Mexico, 5%from Colombia and 5.7% from LAC in general. Half of the studies described the roleof the HTA and EE in decision-making and aspects or policies related to innovation(25% and 23.3%). Regarding the description of the coverage process, it was addressedin 13.3% of the studies; 10% of the publications focused on technovigilance; and also10% on regulatory aspects. Remaining publications were methodological guidelinesand general descriptions of the health systems and the role of medical devices. Allcountries had HTA and EE guidelines, although there did not include device specificrecommendations. There is a spectrum of HTA formalization for technology incorporationafter licensing, higher in Brazil and lower in Argentina Conclusions:There is scarce information on the processes and requirements to achieve coveragefor medical devices in these countries. Processes differ, are in general not explicit,lack transparency, and usually replicate those of drugs not taking into account thespecificities of medical devices.
dc.format
application/pdf
dc.language.iso
eng
dc.publisher
Expert Reviews
dc.rights
info:eu-repo/semantics/openAccess
dc.rights.uri
https://creativecommons.org/licenses/by-nc-sa/2.5/ar/
dc.subject
Medical Devices
dc.subject
Licensing
dc.subject
Coverage
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Reimbursement
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Latin America
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Medicina Critica y de Emergencia
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Medicina Clínica
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CIENCIAS MÉDICAS Y DE LA SALUD
dc.title
Medical devices: from licensing to coverage. highlights from Argentina, Brazil, Colombia and Mexico
dc.type
info:eu-repo/semantics/article
dc.type
info:ar-repo/semantics/artículo
dc.type
info:eu-repo/semantics/publishedVersion
dc.date.updated
2018-05-31T15:03:55Z
dc.journal.volume
13
dc.journal.number
11
dc.journal.pagination
1053-1065
dc.journal.pais
Estados Unidos
dc.journal.ciudad
Abingdon
dc.description.fil
Fil: Rey Ares, Lucila. Instituto de Efectividad Clínica y Sanitaria; Argentina
dc.description.fil
Fil: Hernández Vásquez, Akram. Instituto de Efectividad Clínica y Sanitaria; Argentina
dc.description.fil
Fil: Garay, Osvaldo Ulises. Instituto de Efectividad Clínica y Sanitaria; Argentina
dc.description.fil
Fil: Pichón-Riviere, Andrés. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentina
dc.description.fil
Fil: García Martí, Sebastián. Instituto de Efectividad Clínica y Sanitaria; Argentina
dc.description.fil
Fil: Gilardino, Ramiro. Johnson & Johnson Medical Companies; Argentina
dc.description.fil
Fil: Cabra, Hermilio Arturo. Johnson & Johnson Medical Companies; Argentina
dc.description.fil
Fil: Augustovski, Federico Ariel. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentina
dc.journal.title
Expert Review of Medical Devices
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/doi/https://dx.doi.org/10.1080/17434440.2016.1245611
dc.relation.alternativeid
info:eu-repo/semantics/altIdentifier/url/https://www.tandfonline.com/doi/full/10.1080/17434440.2016.1245611#
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