Venezuela offers unique advantages for first-in-human medical device clinical trials including 40-60% cost savings vs traditional LATAM destinations, experienced investigators, SACS device registration in ~20 business days, and fully operational private hospitals. bioaccess® is the first CRO with FIH operations in Venezuela.
Key Takeaways Venezuela offers 40-60% cost savings compared to traditional LATAM FIH destinations Medical device registration through SACS takes approximately 20 business days Devices imported by MPPS-accredited institutions for testing may qualify for regulatory exemptions Private hospital sector operates at 100% capacity with modern surgical infrastructure Venezuela complements bioaccess® FIH programs in El Salvador, Panama, and Colombia ISO 9001 and ISO 13485 certification required for manufacturers First-in-human (FIH) studies are among the most critical milestones in a medical device's clinical development journey. They require experienced investigators, appropriate patient populations, supportive regulatory environments, and cost-effective operations. Venezuela is emerging as a compelling destination for FIH medical device studies, complementing bioaccess®'s established First-in-Human FastTrack™ programs in El Salvador, Panama, and Colombia. The FIH Opportunity in Venezuela for …