Alignment of the Cuban medical devices regulatory framework with international trends

Abstract

Introduction: The Cuban Regulatory Program promotes regulatory convergence, based on the application of international standards and practices. For this purpose, it draws on the guidelines of the International Medical Device Regulators Forum (IMDRF), an organization established to accelerate regulatory convergence and international harmonization of medical devices, thus promoting an efficient and effective regulatory model.

Objective: Analyzing the update of the Cuban regulation of medical devices; evaluating its alignment with international recommendations; and identifying strengths and potentialities.

Methods: A retrospective, descriptive and longitudinal study of the Cuban regulatory documents for medical devices issued in the period between 2008 and 2024 was made. A quantitative analysis of coincidence with the IMDRF documents in same period was carried out in terms of level of implementation and regulatory functions.

Results: In the period studied, 69 regulatory documents for medical devices were issued. Of these, 29 are updates. 49 technical documents issued by the Global Harmonization Task Force (GHTF) and its successor, the IMDRF, were evaluated, of which 36 were implemented by State Control Center of Medicines and Medical Devices (CECMED) regulations, for 73.5%.

Conclusions: The implementation of IMDRF documents in Cuban regulations is similar and even superior to that of other member countries, which places CECMED in a favorable position to apply as an Official Observer of the Organization.