bioaccess® Knowledge Base

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.

Featured articles

• INVIMA Medical Device Approval Timeline in Colombia — INVIMA medical device approval in Colombia typically ranges from 3 to 12 months, depending on the device class and type of approval (sanitary registration vs. clinical trial permit). bioaccess® can accelerate this timeli
• 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
• Clinical Trial Costs in Latin America: 2026 Benchmarks — Clinical trial costs in Latin America are approximately 30% lower per-patient and trial timelines are materially faster than in the US/EU, driven by favorable regulatory environments and efficient site operations across
• 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

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