Vetted answers to the questions MedTech, Biopharma, and Radiopharma sponsors ask most before running a first-in-human trial in Latin America — regulatory pathways, timelines, costs, and FDA acceptance.
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INVIMA Medical Device Approval Timeline in Colombia — INVIMA medical device approval in Colombia typically varies by study (we confirm it per protocol), depending on the device class and type of approval (sanitary registration vs. clinical trial permit). bioaccess® helps ke
First-in-Human (FIH) Studies: What Sponsors Need to Know — First-in-Human (FIH) medical device studies are initial clinical investigations in humans, crucial for evaluating safety and preliminary performance. They are required when non-clinical data supports potential safety and
Does the FDA Accept Clinical Trial Data from Latin America? — Yes, the FDA accepts clinical trial data from Latin America when studies adhere to FDA regulations, including 21 CFR 312.120 for non-IND studies and 21 CFR 812.28 for medical devices, and demonstrate compliance with Good