MDRC Overview Presentation Latin America

SA2-MDRC builds upon and updates the results from the first phase of the Standards Alliance in Latin America, shifting the geographic scope to include Brazil and introduce the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector with a permanent Technical Secretariat to increase the Standards Alliance activity and organization to a higher order of magnitude. The MDRC Project Countries in Latin America are: Brazil, Colombia, Mexico, and Peru. MDRC’s regional objectives in Latin America are:

Foster implementation of foundational GRPs that codify good governance in the regulatory process, focusing on transparency, predictability, accountability, and international convergence;
Foster implementation of medical device sector-specific convergence in regulations, standards, and conformity assessment to reduce unnecessary non-tariff barriers;
Establish the novel Inter-American Coalition for Regulatory Convergence with the vision of “one standard, one test, accepted everywhere” to accelerate private-public cooperation in support of medical device regulatory convergence through the use of international standards;
Assist customs authorities in understanding and following the import criteria and policies set by the health authorities addressing COVID-19.

Details on the activities developed under the project in the Latin American countries such as events, materials, trainings, etc. can be found at the Inter-American Coalition for Regulatory Convergence in the Medical Technology Sector.