X Meeting of Regulatory Authorities for the Strengthening of the Regulatory Capacity of Medical Devices in the Americas

The Pan American Health Organization (PAHO) organized the X Meeting of Regulatory Authorities for the Strengthening of the Regulatory Capacity of Medical Devices in the Americas, from June 1 to 3 2022, in the context of the activities of the Regional Working Group on Medical Device Regulation.

During 1-2 June, the open session took place with 255 participants from 19 countries, including regulators, industry representatives, and other interested parties. Topics discussed included an update of the activities of the Regional Working Group, Good Regulatory Practices for Medical Devices, and reliance in the Authorization for Emergency Use of Medical devices. On the afternoon of 2 June and the morning of 3 June, the closed session took place with the attendance of 116 participants from 14 countries in the Region. Among the attendees were directors, unit chiefs, reviewers, department managers and professionals specialized in medical devices from the NRAs of Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Costa Rica, Cuba, El Salvador, United States of America, Guatemala, Honduras, Mexico, and Uruguay.

The agenda included updates on topics related to the regulation of medical devices, including the different activities of the Regional Working Group, the World Health Organization, and the International Medical Device Regulators Forum (IMDRF).

Additionally, the first roundtable on the regulation of assistive products in the Region was held, during which the NRAs of Brazil, Argentina, Cuba, and Colombia exchanged their experience in regulating these products for people living with functional difficulties.