THINKING OF DOING BUSINESS IN LATIN AMERICA? DO YOUR HOMEWORK FIRST
Economic growth and a desire to improve the overall quality of and access to healthcare services should make Latin America an enticing market for medical device manufacturers. Yet navigating the disparate regulatory systems can prove challenging for even the most seasoned regulatory professional.
Eliana Silva de Moraes, president of the Brazilian Regulatory Affairs Professional Society, offered advice to devicemakers at the annual Regulatory Affairs Professionals Society meeting in October.
All of the 21 countries in Latin America require product registration, a CE mark and a local distributor who is authorized to market a company's products and has the necessary permits. Beyond that, there is little harmonization in the region -- although that is beginning to change.
Manufacturers need to understand the economic environment of the region and the administrative laws and procedures of the different countries before entering the marketplace, de Moraes said. A free-trade agreement between Brazil, Argentina, Uruguay and Paraguay, with Chile and Bolivia as associate states, is working, "but they don't have common regulations for medical devices," she said. "You have to go to each country to register your product."