FIME and the Latin American Dream

Consultant Richard Vincins addressed this year’s FIME medical trade fair audience in Miami on the ins and outs of getting device approval in Latin America

He focused on countries with established regulatory systems, including Brazil, Argentina, Colombia and Chile. For countries without good regulation, Vincins explained how devices are classified and whether approval in another country is recognized. Moreover, having a local representative who speaks the language and knows the terrain, and having home-country approval can facilitate and accelerate the registration process. Trends include the establishment of new regulations in certain countries, while others have none at all or standards dating to the 1960s or ‘70s.