In July 2022 I mapped Latin America's medtech clinical trial landscape: why U.S. startups go outside the U.S. for early feasibility studies, and which countries were ready. Four years later, the map has been redrawn — new rulebooks, new clocks, and a new strategic role for the U.S. itself.
September 30, 2026
9
min read
By
Julio G. Martinez-Clark, CEO, bioaccess®
Latin America
Clinical Trials
First-in-Human
Early Feasibility Studies
Medical Devices
Regulatory
In short
In July 2022, Julio Martinez-Clark mapped Latin America's medtech clinical trial landscape: U.S. startups go outside the U.S. for early feasibility and first-in-human studies because domestic development is too slow and expensive — the Medical Device Innovation Consortium estimated about 6.5 years and $37 million from bench testing to EFS or FIH completion in the U.S. By 2026, the landscape has shifted: Panama enacted Decreto 21 (April 2026) with accredited ethics committees and a mandatory national registry; Brazil modernized clinical research under Law 14.874/24; Chile's easy-entry era has an expiration date around 2028; and FDA's Early Feasibility Study program is moving toward “EFS 2.0,” making the U.S.-versus-Latin-America choice strategic rather than merely cost-driven. Under 21 CFR 812.28, FDA accepts the Latin American data back into a U.S. submission when the study is run under GCP with adequate documentation.
The source article. This post is a 2026 update of “Latin America's Landscape For Medtech Clinical Trials”, published on Med Device Online on July 5, 2022. Every figure below attributed to that article is explicitly its 2022 vintage — the point of this update is what still holds and what changed.
What the 2022 article established
The 2022 article started from the economics of the U.S. medtech startup. Writing in 2022, it noted there were over 6,500 MedTech companies in the U.S., more than 80% with fewer than 50 employees — companies with limited financial resources and minimal to no sales revenue. For those companies, the article argued, waiting for long-drawn-out ethics and regulatory approval on an early feasibility study (EFS) or a first-in-human (FIH) study could tie up investment dollars and lead a startup to starvation.
It set out the FDA's own definitions — an EFS is a limited clinical investigation of a device early in development, typically enrolling a few subjects (fewer than 15), evaluating the device design concept for initial clinical safety and device functionality, and potentially guiding device modifications; an FIH study is the first clinical use of the device for a specific indication, and an FIH can be an EFS but not all FIH studies are EFSs. And it put numbers on the domestic burden, all 2022 vintage: the Medical Device Innovation Consortium estimated about six and a half years and $37 million to bring a device from bench testing to completion of an EFS or FIH in the U.S.; a delayed development program costs sponsors roughly $37,000 in operational costs each day; and medtech companies were seeing about 320 days from site dossier packet received to first patient enrolled on U.S. EFS work.
The conclusion in 2022: the unpredictable, inefficient, and expensive regulatory process for conducting an EFS or FIH in the U.S. forces startups to conduct outside-the-U.S. research, where regulatory hurdles are more favorable and it is easier and faster to recruit subjects at lower cost — with the EU Medical Device Regulation of 2021 pushing companies out of Europe as well, toward emerging markets like Latin America.
The 2022 destination map
In 2022, the traditional OUS EFS/FIH map covered Australia, New Zealand, and several other regions alongside Latin America. Within Latin America, the article profiled four countries in detail — and this is where the 2026 update gets interesting, because each one has moved:
- Colombia. The 2022 hotspot: INVIMA's medical device committee met every 30 days on a published schedule, making it, in the article's assessment, the fastest regulatory agency in Latin America for device-trial approval. The article cited close to $120 million in foreign clinical research funding inflow and over 20,000 subjects treated — both 2022-vintage figures.
- Paraguay. Since Resolution 614 of December 2016, a robust approval framework with three-to-four-month timelines; pioneer investigator Adrian Ebner had been involved in more than 70 first-in-human studies. The article flagged industry concerns about corruption in the approval process and light GCP oversight — caveats that still deserve respect in 2026.
- Panama. Law 84 of May 14, 2019 had updated the clinical trial regulations, with a three-to-four-month central ethics review and 11 accredited ethics committees — but the 2022 article judged Panama “too small to ensure fast recruitment,” with device-trial activity limited to five private hospitals in Panama City.
- Chile. About 19 million people and a three-to-four-month ethics review, but no mandatory medical device regulation and no clear device-trial pathway — clinical trial regulations had not been updated since Law 20120 of 2006.
The 2022 evidence base for the region: per ClinicalTrials.gov, 67 medical device trials in Latin America in 2020 — a 67.5% increase from 40 in 2017. And the success cases the article documented read like a who's-who of the era: enVVeno's VenoValve (the legacy enVVeno valve program, then an FDA-designated Breakthrough Device) FIH in Colombia with 11 subjects, Spine Stabilization Technologies' post-market follow-up in Colombia, Urotronic's Optilume FIH in Panama, Artio Medical's Amplifi FIH in Paraguay.
What changed by 2026
Four years on, the 2022 diagnosis — startups can't survive domestic EFS timelines — still holds. What changed is the map itself:
| Country | The 2022 picture | The 2026 picture |
|---|---|---|
| Panama | Law 84 (2019) but 'too small' for recruitment | Decreto 21 of April 23, 2026: accredited ethics committees, the mandatory RESEGIS national registry, statutory review timelines, codified sponsor duties — an operating rulebook, not just principles |
| Brazil | Slowest approvals in the region (90-day statutory, 120–180 days actual) | Law 14.874/24 modernized the clinical research framework; ANVISA now operates under firm review clocks for device studies |
| Chile | No mandatory device regulation; Law 20120 (2006) untouched | Easy-entry era has an expiration date: a new decree arriving around 2028 hits high-risk, technically complex products hardest |
| Mexico | Second-slowest; 90-day statutory, 45–60 days actual | COFEPRIS digitization push under way; proximity and scale (130M+ people) intact |
| Colombia | Fastest device-trial regulator (INVIMA monthly committee) | Still the predictable committee; Bill 191 keeps Colombia's research-incentive conversation alive |
Beyond the four original profiles, new names belong on the 2026 map. El Salvador has built a favorable FIH framework. Georgia deserves a fresh look rather than a default slot. And Australia's headline R&D tax incentive needs a true-cost accounting before it anchors a program — the subject of our companion analysis.
The most important structural shift, though, is on the U.S. side. FDA's Early Feasibility Study program is growing toward what the agency conversation now calls “EFS 2.0” — FDA explicitly wants early U.S. clinical experience with novel devices, is approving EFS IDEs in the first 30-day review cycle, and recognizes the value of multigeography studies rather than insisting on U.S.-only work. That doesn't invalidate the Latin American first-in-human; it makes the U.S.-versus-Latin-America decision strategic rather than merely cost-driven — which is the subject of our companion 2026 update on why U.S. companies go overseas.
Will the FDA accept the data?
The 2022 article summarized FDA's position as two conditions: GCP compliance and the agency's ability to validate the data through on-site inspection, with a documentation package covering investigators, facilities, protocol, devices, and ethics decisions. The governing regulation — 21 CFR 812.28 — still frames acceptance the same way in 2026: foreign clinical data is accepted when the study is conducted under good clinical practice with adequate documentation, and the data are scientifically valid.
The 2026 refinement is operational, not legal: sponsors now design for repatriation from day one. The overseas EFS/FIH generates the early clinical evidence; the dataset returns home to support an IDE or a Breakthrough Device submission. That repatriation step — barely discussed in 2022 — is now the center of the conversation, and it is why the geography decision has to be made with the U.S. submission in mind from the start.
Choosing an EFS/FIH destination in 2026
The 2022 article closed with seven areas for country-level feasibility — and they remain the right checklist in 2026:
- Subject recruitment potential
- Regulatory and ethical approval processes and timelines
- Sites' capabilities, qualified staff, and resource availability
- Regulatory benefits and incentives
- Confirmation of data acceptance
- Overall project costs
- Details on clinical trial shipment and connectivity
What the 2026 update adds to that checklist is the geography question the 2022 article didn't have to answer: U.S. EFS or Latin America FIH? Choose U.S. EFS when early FDA interaction and U.S. site experience matter most to the program. Choose Latin America FIH when activation speed and enrollment throughput matter most. See our early feasibility studies overview and first-in-human CRO services for how the two fit together.
Our position, stated plainly: bioaccess advises on U.S. EFS versus Latin America FIH strategy from Miami and executes first-in-human trials across 19 Latin American and Caribbean countries. We tell sponsors honestly which geography their program needs rather than selling one answer.
Frequently asked questions
What is the fastest next step?
Send us your protocol synopsis, your cohort size, and your target first-patient-in date, and we will tell you plainly which geography your program needs — U.S. EFS or Latin America FIH — including the cases where staying where you are is the right call. Get a first-in-human feasibility read in 72 hours.
Get your feasibility read
Explore our FIH services