title: [Regulatory Program for Medical Devices in Cuba: experiences and current challenges].
abstract: Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.
authors.forename: Dulce María Martínez
authors.initials: DM
authors.lastname: Pereira
authors.forename: Yadira Álvarez
authors.initials: YÁ
authors.lastname: Rodríguez
authors.forename: Yamila Cedeño
authors.initials: YC
authors.lastname: Valdés
authors.forename: Silvia Delgado
authors.initials: SD
authors.lastname: Ribas
mesh_terms: D003462:Cuba; D006291:Health Policy; D006801:Humans; D062307:Medical Device Legislation; D009313:National Health Programs