On May 8, 2026, 98 MedTech professionals from 17 countries joined our Friday In Focus webinar on running first-in-human (FIH) clinical trials in Latin America. 59% stayed past 46 minutes in a 62-minute session — and they didn’t ask curiosity questions. They asked execution questions: country selection, ethics, FDA acceptability, statistical power, step-by-step playbooks for medical device sponsors who are actively planning their first FIH outside the United States.
If you’re evaluating whether to run your next first-in-human study in Latin America, here are the five questions your peers pushed hardest on — and how to think about each one before you commit to a country, an ethics committee, or an FDA submission strategy.
1. Which country in Latin America is the easiest?
This was the first question out of the gate, asked by Rocío Paublete (Sweden, PMCF & Clinical Investigation Project Manager) and echoed throughout the chat. The honest answer is: it depends on what you’re optimizing for.
“Easy” decomposes into three orthogonal dimensions:
- Patient recruitment speed — how quickly you can enroll the first 5–30 patients for an FIH or early feasibility study. Colombia, Mexico, and Brazil typically lead here because of dense urban hospital networks and high physician engagement with research.
- Ethics committee turnaround — how long the IRB/CEI review cycle takes from submission to approval. Chile and Costa Rica run faster review cycles than Brazil, where amendments through CONEP can stretch.
- Regulatory authority predictability — INVIMA (Colombia), ANVISA (Brazil), COFEPRIS (Mexico), ANMAT (Argentina), DIGEMID (Peru), and ISP (Chile) all have different timelines, fee structures, and documentation expectations.
For most US-headquartered MedTech sponsors running an FIH, the practical sweet spot is Colombia or Costa Rica for first-patient-in speed, with Brazil considered when the indication requires larger patient diversity or when the eventual commercial path runs through Latin America’s largest market.
2. Are those countries easier because of recruitment, or because of ethics committees?
Rocío came back with this follow-up — and it’s the right one to ask. The two drivers behave differently:
- Recruitment speed is largely a function of investigator network density, hospital infrastructure, and patient population. It’s a relatively stable property of the country and the indication.
- Ethics committee speed varies by which committee, not just which country. A Bogotá-based academic medical center’s CEI may turn around in 4–6 weeks; a regional committee might take 12. The same country can deliver dramatically different timelines depending on site selection.
The implication for sponsors: pick countries where both the recruitment and the committee math work, then pick sites where you’ve already mapped CEI cycle times empirically. Don’t optimize one without the other.
3. Will the FDA accept clinical data generated in Latin America?
This question, from Bhavik Gondaliya (Germany, RA), is the one that gates every conversation about whether LatAm FIH data will actually contribute to a US regulatory submission. The short answer: yes, with conditions.
The FDA’s longstanding position on foreign clinical data is codified in 21 CFR 814.15 for PMA submissions and reflected in their 2018 guidance “Acceptance of Clinical Data to Support Medical Device Applications and Submissions.” LatAm data is acceptable if:
- The study was conducted in accordance with Good Clinical Practice (GCP), including independent ethics review and informed consent
- The data are applicable to the US patient population (the FDA looks for population overlap on the relevant clinical and demographic axes)
- The site investigators were qualified, the protocol was scientifically sound, and the data are auditable by FDA inspectors
For most early-stage MedTech sponsors, the practical playbook is to design the LatAm FIH so that its protocol, endpoints, and case report forms look like what an FDA reviewer would expect to see in a US pivotal study. Doing this work upfront makes the eventual bridging to a US IDE or 510(k)/De Novo dramatically smoother.
4. How do you handle the ethics of providing investigational therapy “for free” in lower-resource settings?
Nyerngoor Korda Hewitt (UK, Director of Regulatory Affairs and Quality) raised this — and it’s a question every sponsor should be ready for. The concern is real: when an FIH protocol provides expensive investigational therapy at no cost in a country where standard care is often unaffordable, you can create undue inducement.
The frameworks that govern this are well-established — the Declaration of Helsinki (especially Articles 19–20 on vulnerable populations), the Council for International Organizations of Medical Sciences (CIOMS) International Ethical Guidelines, and country-specific implementations. Operationally, robust sponsors design their LatAm FIH protocols to address inducement directly:
- Post-trial access — explicit commitments about whether participants will continue to receive the therapy after the trial ends, and under what conditions
- Standard-of-care arms — when ethically and statistically appropriate, designing comparator arms so participants aren’t forced to choose between trial enrollment and accessible care
- Independent ethics review in the host country, with documented review of the inducement question by the local CEI
- Community engagement — particularly for indications where the trial may shape future access in the country
The audience response on this question made clear: it’s a topic experienced sponsors and their RA teams take seriously, and one ethics committees in Colombia, Mexico, Chile, and elsewhere actively probe.
5. Step-by-step: I have a de novo medical device and I want to do FIH in Panama or Bolivia. What does it actually look like?
This question, from Joseph Skraba (University of Texas at Austin, Manager of Medical Device Commercialization), was the most operational of the session. Here’s the compressed playbook for a de novo Class II/III medical device sponsor:
- Pre-clinical foundation — bench testing, biocompatibility (ISO 10993), sterilization validation, and animal study data sufficient to support first human exposure. This is non-negotiable.
- FDA pre-submission (Q-Sub) is optional but strongly recommended — even for studies conducted entirely outside the US, a Q-Sub conversation aligns the FDA’s expectations for how the foreign data will support a future US submission. This is “free insurance” for your eventual regulatory path.
- Export approval — for a non-US-cleared device, you’ll need an FDA Export Certificate (typically a Certificate to Foreign Government, CFG) under Section 801(e) of the FD&C Act. Lead time is usually 4–6 weeks.
- In-country regulatory approval — country-specific medical device authorization. INVIMA (Colombia) and ANMAT (Argentina) have streamlined pathways for clinical investigation devices; smaller markets like Panama and Bolivia rely on Ministry of Health approvals that vary in predictability. Plan 8–16 weeks.
- Ethics committee review — single-site or multi-site CEI approval. Allow 4–12 weeks depending on country and committee. Many sponsors run this in parallel with regulatory.
- Site activation — investigator agreements, indemnification (and clinical trial insurance — required in most LatAm countries), training on the IFU and protocol, IRT/EDC system rollout.
- First-patient-in — typically 6–9 months from kickoff for a well-prepared sponsor, faster with an experienced in-country CRO.
The realistic end-to-end timeline from contracting to first-patient-in is 6–9 months for sponsors who arrive prepared, longer for sponsors who try to compress pre-clinical or skip the FDA Q-Sub.
Bonus: “Statistical power with 5 patients?”
Stephanie Grassmann (Switzerland, MedTechXperts LLC) lobbed this one in — and the answer is: FIH studies aren’t powered for inferential statistics, and that’s by design.
An FIH/early-feasibility study (typically 5–30 patients) is designed to evaluate safety, device handling, procedural success, and preliminary signals of efficacy. The endpoints are descriptive: rates, intervals, mean changes from baseline. The next study (pilot or pivotal, often 50–300+ patients) is where powered hypothesis testing begins. The two studies serve different scientific purposes and are evaluated by the FDA on different criteria.
For sponsors evaluating whether their LatAm FIH will “count” toward their eventual US submission: it counts if it answers the questions a 5–30 patient study is designed to answer. Don’t try to make it carry weight it wasn’t designed to bear.
Who was in the room
The 98 attendees came from 17 countries across North America, Europe, Latin America, and Asia, with roles ranging from Regulatory Affairs leaders and Quality directors to MedTech founders and CEOs. The session ran from 11:00 AM to 12:02 PM ET on Friday, May 8, 2026, and 20% of listeners stayed for the final two minutes — an engagement signal that tracks with the seriousness of the questions asked.
Next steps for your team
If your team is actively planning a first-in-human study and wrestling with any of the questions above, here’s how to move forward:
- Free 30-minute feasibility screen — share your indication, target patient count, and target FPI date, and we’ll tell you which 2–3 LatAm countries are realistic for your specific case. Book a call →
- Read the case studies — bioaccess® has supported FIH and early-feasibility studies for cardiology, neurology, ophthalmology, and orthopedic device sponsors across Colombia, Mexico, Chile, Costa Rica, and Brazil. See recent case studies →
- Stay current — we publish new analyses of LatAm regulatory shifts (ANVISA’s 2026–2027 international convergence agenda, FDA’s December 2025 RWE guidance and what it means for LatAm data, ophthalmic FIH dynamics in smaller markets) every week. Subscribe via the form below.
Thanks to the 98 MedTech professionals who joined the session, and to the panelists and moderators who made the depth of the discussion possible. The next Friday In Focus session will be announced shortly.