[Regulatory Program for Medical Devices in Cuba: experiences and current challenges]

Area of Science:

• Health policy
• Medical device regulation
• Public health systems

Background:

• Cuba's National Health System utilizes a Regulatory Program for Medical Devices, established in 1992.
• This program aims to ensure the safety, efficacy, and effectiveness of medical technologies.
• Progress has been made through successive stages and integrated regulatory activities for drugs and medical equipment.

Purpose of the Study:

• To outline the evolution and current state of Cuba's medical device regulatory system.
• To identify key challenges and future directions for regulatory control.
• To highlight the role of the Collaborating Centre in advancing regulatory strategies.

Main Methods:

• Review of the historical development of the Cuban regulatory program.
• Analysis of current challenges including scientific evaluation, risk management, and international standards.
• Examination of future strategies such as ISO 13485 implementation and market surveillance.

Main Results:

• The Cuban regulatory system has evolved towards greater transparency and control.
• Current challenges include integrating scientific evaluation, risk assessment, and international standards.
• Future efforts focus on ISO 13485, market monitoring, and device classification aligned with national health policies.

Conclusions:

• Cuba's medical device regulatory program has demonstrated resilience and progress.
• Key future priorities include enhancing scientific rigor, adopting international standards, and fostering regional regulatory convergence.
• The Collaborating Centre will support these strategic advancements for health technologies.