Latin America the ‘hidden gem’ for first-in-human medical device trials

A Clinical Research News article on August 14 2025 reports that Latin America is becoming a key region for “first-in-human” medical-device trials. Many medtech companies face obstacles in the U.S. or Europe—such as participant-shortage, long regulatory timelines or high costs—and are therefore turning to Latin American countries that offer faster ethics/regulation approval, adequate local investigators and lower cost. 

Countries such as Panama, El Salvador, Chile, Paraguay and the Dominican Republic are cited as examples where ethical/regulatory approval can be secured more quickly. This positions the region as a strategic alternative for startups seeking to accelerate time-to-market. However, the article emphasises that clinical-trial infrastructure (especially for higher-risk devices) still needs development: in many cases, hospitals lack the level of sophistication seen in Europe, so manufacturers must plan extra support, training and tailored logistics.

The piece further notes that this trend is significant for the med-tech sector: beyond importation and registration, it becomes about where to develop, test and launch innovations. For importers and distributors in Latin America, the country chosen for the trial may impact market-access timing, product credibility and launch strategy.

Sources:

• “Latin America the ‘Hidden Gem’ for First-in-Human Medical Device Trials.” . Link