An updated overview of the regulatory requirements for medical devices, including IVDs, in Cuba
£50.00
Get up to speed on Cuba’s latest regulatory developments, including new provisions covering both medical devices and IVDs, and what they mean for market access and compliance
English
Content summary:
The evolution of the Cuban regulatory framework for medical devices has been closely linked to the development of its regulatory institutions, the work experience acquired, legislative evolution at the national government level, and the implementation of recommendations from international bodies and organisations.
This article by Mario César Muñiz Ferrer and Yadira Álvarez Rodríguez aims to update the legislative and regulatory context for medical devices in Cuba from their 2022 article published in the Journal of Medical Device Regulation. Recent analyses of the updated Cuban legal framework have led to the development of regulatory provisions that, in their scope, include both medical devices and in vitro diagnostic medical devices. The main regulatory controls are currently defined in the CECMED Policy for the Regulation of Medical Devices, considered a milestone in Cuban regulatory practice. In the period 2022–2025, the regulatory functions of marketing authorisation, establishment licences, and regulatory audits have undergone the most significant changes. The next stages of development of the technical and legal framework for medical devices in Cuba will be linked to strategies to update and expand the market surveillance and control systems.
About the authors:
Dr. Mario César Muñiz Ferrer, CECMED. First Degree Specialist in General Medicine. He has held numerous responsibilities within the Cuban Health System. Since 2019 he has served as Head of Department of Medical Devices of CECMED. He is Director (2022–2026) of the PAHO/WHO CUB-26 Collaborating Center for the Regulation of Health Technologies. He has completed international missions in Venezuela and Guatemala, and has participated in national and international scientific publications and events. He has taught courses and participated in research projects.
Yadira Álvarez Rodríguez MSc., CECMED. Master’s Degree in Public Health Sciences. She has an experience of 30 years’ work at the regulatory authority. She has participated in scientific publications, national and international events, research projects and in courses relating to the regulatory issue of medical devices. She is Co-Director (2022–2026) of the PAHO/WHO CUB-26 Collaborating Center for the Regulation of Health Technologies.
Specification:
13 pages plus covers in English and 14 pages plus covers in Spanish, supplied by email as a PDF.
The English and Spanish versions of this article have been published in the May 2026 issue of the Journal of Medical Device Regulation.
