Medical devices: from licensing to coverage. highlights from Argentina, Brazil, Colombia and Mexico

Lucila Rey-Ares, Akram Hernández-Vásquez, Osvaldo Ulises Garay, Andrés Pichon Riviere, Sebastián Garcia Marti, Ramiro Gilardino, Hermilio Arturo Cabra, Federico Augustovski

Research output: Contribution to journalArticlepeer-review

1 Scopus citations


Objectives: To describe and compare the requirements for medical devices licensing and reimbursement in four Latin-American countries. Methods: We conducted a literature search in major databases, and generic Internet engines, and interviewed key informants. Results: We included all publications describing regulation and/or coverage and enriched them with key informant’s interviews. We found that licensing processes are similar. The decision-making process for coverage is not formally different than the one used for drugs. Although countries differ, Brazil, Colombia and Mexico have an explicit process informed by Health Technology Assessment. In general, coverage policies are defined for procedures and don´t specify device brand or model, and for that reason they may reimburse without explicit one by one device evaluation. Conclusions: The process for licensing and reimbursement is broadly similar but less stringent than that for drugs. It allows the adoption of medical devices without individual comprehensive assessment.

Original languageEnglish
Pages (from-to)1053-1065
Number of pages13
JournalExpert Review of Medical Devices
Issue number11
StatePublished - 1 Nov 2016
Externally publishedYes


  • Latin America
  • Medical devices
  • coverage
  • licensing
  • reimbursement


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