OBJECTIVES: To assess, describe and compare the requirements and pathways of 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 searched specific 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 information related to the aforementioned processes. We present here the literature search results. RESULTS: We included 60 studies out of 2190. Five percent of the publications analyzed 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 role of 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 addressed in 13.3% of the studies; 10% of the publications focused on technovigilance; and also 10% on regulatory aspects. Remaining publications were methodological guidelines and general descriptions of the health systems and the role of medical devices. All countries had HTA and EE guidelines, although there did not include device specific recommendations. There is a spectrum of HTA formalization for technology incorporation after licensing, higher in Brazil and lower in Argentina CONCLUSIONS: There is scarce information on the processes and requirements to achieve coverage for medical devices in these countries. Processes differ, are in general not explicit, lack transparency, and usually replicate those of drugs not taking into account the specificities of medical devices.