The XI Regional Meeting on Medical Device Regulation is being held with the participation - in person and virtually - of 22 countries of the Region of the Americas with the purpose of promoting the strengthening of the regulatory capacity of the National Regulatory Authorities (NRA) in the Region in the field of medical devices, through strategies for the achievement of joint objectives, exchange of experiences and strengthening of collaboration between countries. This event was organized by the Pan American Health Organization (PAHO), in collaboration with the National Directorate of Medicines (DNM) and the Salvadoran Social Security Institute (ISSS).
Participants included representatives from NRA members of the Regional Working Group on Medical Device Regulation, the medical device industry, including members of the Inter-American Coalition for Regulatory Convergence for the Medical Technology Sector, and representatives from the academia. The agenda of this event was divided into two parts: an open session, which promotes dialogue between regulators, industry representatives and other stakeholders; and a closed one, in which regulators meet.
The Head a.i. of PAHO's Access to Medicines and Health Technologies (*IMT/AH) unit, Eng. Alexandre Lemgruber, opened the meeting by stating that this regional group has traveled a road of eleven years of successes, challenges, and much work to be done. He added that “this is the first face-to-face meeting after the pandemic, and we hope that the work of these days will be very fruitful”. He thanked the health authorities of El Salvador and the PAHO country team for their support in organizing the meeting.
The regulatory system is essential in the health system and is responsible for regulating health technologies so that they meet safety, quality and performance standards; promoting equitable access and contributing to economic and social development. Strengthening regulatory systems remains a public health priority for PAHO’s Member States.
Following up with the opening remarks, Dr. Giovanni Escalante, PAHO El Salvador Representative, , stated that "it is important to highlight that expanding regulatory and analytical capacity will improve the population's access to quality and safe devices. This working group has a solid track record of work since 2012, and PAHO is proud to be in charge of the Secretariat. Our main objective is to strengthen the regulatory capacity for medical devices in the countries of the Region."
This meeting has, among other objectives, to discuss, to propose and to establish the priority areas and activities at the regional level in the regulation of medical devices; as well as to agree on a work plan for 2024 and establish commitments for its proper implementation.
Since its creation, the Regional Working Group has developed activities for capacity building of NRA, collaboration between countries and with the International Medical Device Regulators Forum (IMDRF), as well as the establishment of the Program for the Exchange of Adverse Event Reporting of Medical Devices in the Americas (REDMA Program), among other initiatives. Twenty-five (25) NRA are currently members of the Regional Working Group.
*The IMT Department helps countries to strengthen their regulatory capacity, to address access barriers and challenges throughout the entire life cycle of the medical product, and to support evidence-based decision making and rational use through health technology assessment.
IMT is responsible for promoting, coordinating and implementing the Organization's technical cooperation on access to and rational use of quality medicines and other health technologies. It works in all categories of medicines and health technologies, including medicines, vaccines, medical devices, blood products and organs for transplantation.
