title: Medical devices: from licensing to coverage. highlights from Argentina, Brazil, Colombia and Mexico.
abstract: OBJECTIVE
  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.
authors.affiliation: a Institute for Clinical Effectiveness and Health Policy (IECS) , Buenos Aires , Argentina.
authors.forename: Lucila
authors.initials: L
authors.lastname: Rey-Ares
authors.affiliation: a Institute for Clinical Effectiveness and Health Policy (IECS) , Buenos Aires , Argentina.
authors.forename: Akram
authors.initials: A
authors.lastname: Hernández-Vásquez
authors.affiliation: a Institute for Clinical Effectiveness and Health Policy (IECS) , Buenos Aires , Argentina.
authors.forename: Osvaldo Ulises
authors.initials: OU
authors.lastname: Garay
authors.affiliation: a Institute for Clinical Effectiveness and Health Policy (IECS) , Buenos Aires , Argentina.
authors.forename: Andrés
authors.initials: A
authors.lastname: Pichon Riviere
authors.affiliation: a Institute for Clinical Effectiveness and Health Policy (IECS) , Buenos Aires , Argentina.
authors.forename: Sebastián
authors.initials: S
authors.lastname: Garcia Marti
authors.affiliation: b Johnson & Johnson Medical Companies.
authors.forename: Ramiro
authors.initials: R
authors.lastname: Gilardino
authors.affiliation: b Johnson & Johnson Medical Companies.
authors.forename: Hermilio Arturo
authors.initials: HA
authors.lastname: Cabra
authors.affiliation: a Institute for Clinical Effectiveness and Health Policy (IECS) , Buenos Aires , Argentina.
authors.forename: Federico
authors.initials: F
authors.lastname: Augustovski
mesh_terms: D019458:Insurance Coverage; D007349:Insurance, Health, Reimbursement; D008004:Licensure; D062307:Medical Device Legislation; D011358:Product Surveillance, Postmarketing; D013020:South America
keywords: Latin America; Medical devices; coverage; licensing; reimbursement