Situación de la regulación de los dispositivos médicos en la Región de las Américas.

Objective. To describe and analyze the current status of and the challenges involved in the regulation of medical devices in the Region of the Americas and to present the results of the regional mapping exercise, progress toward the development of advanced assessment indicators, and the achievements of the Regional Working Group. Methods. Creating a regional profile on the regulation of medical devices in the Americas is a priority for the Working Group. To this end a tool composed of 45 questions organized into six sections was developed and distributed among 15 countries for self-assessment (the participation rate was 100%). Based on the data received, nine basic indicators were established and an agreement was reached to develop advanced indicators for measuring the extent to which regulatory programs for medical devices were being implemented. Results. Of the 15 countries, 93% have an agency in charge of regulating medical devices. An analysis of individual country performance shows wide variability, with some countries meeting all indicators and others meeting as few as 11%. The mapping also made it possible to generate information on collaborative partnerships, training, and regulation. Conclusions. The results show significant heterogeneity at the regional level. Implementation of advanced indicators will help to identify areas of opportunity and strengths for the development of the regulatory profile. Although progress has been made toward strengthening regulatory programs for medical devices, remaining gaps need to be bridged through strategies and initiatives to be led by the Working Group. [ABSTRACT FROM AUTHOR]