LATAM's Regulatory Framework for Medtech Early Feasibility Studies: A 2026 Update

In November 2022 I mapped the regulatory frameworks for running medtech early feasibility studies in Colombia, Mexico, and Brazil. Four years later, the rulebooks have been rewritten — and the question has shifted from “where can we go?” to “where should the data come home?”

September 30, 2026

10

min read

By

Julio G. Martinez-Clark, CEO, bioaccess®

Latin America

Early Feasibility Studies

Regulatory

Medical Devices

Clinical Trials

FDA

In short

In November 2022, Julio Martinez-Clark mapped the regulatory frameworks for medtech early feasibility studies in Colombia, Mexico, and Brazil: Colombia's INVIMA ran the region's fastest device-trial review on a predictable monthly committee schedule; Mexico's COFEPRIS ran a three-step process with a 90-day statutory decision clock; Brazil was the heaviest lift, with ANVISA actually taking 120 to 180 days. By 2026, Brazil modernized clinical research under Law 14.874/24 with firm ANVISA review clocks; Panama enacted Decreto 21 (April 2026), giving Ley 84 an operating rulebook; and FDA's Early Feasibility Study program is moving toward “EFS 2.0.” Under 21 CFR 812.28, the Latin American data comes home 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 “LATAM's Regulatory Framework For Medtech Early Feasibility Studies”, published on Med Device Online on November 11, 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 began with the definition that still anchors the field. An early feasibility study has four elements: (a) a small number of subjects; (b) a device that may be early in development, typically before the design is finalized; (c) initial insights into proof of principle and safety; and (d) a study that does not necessarily involve the first clinical use of a device. That definition has not changed in 2026 — what changed is where, and how fast, you can run one.

The 2022 premise: an EFS in the U.S. traditionally took about a year to start, and medtech companies were seeing roughly 320 days from site dossier packet received to first patient enrolled (2022 vintage). The difficulty of recruiting patients plus the unpredictable, inefficient, and expensive U.S. regulatory process pushed startups toward outside-the-U.S. research — Latin America, where trial regulatory hurdles were more favorable and recruitment was easier, faster, and cheaper. A June 2022 PAHO meeting with the national regulatory authorities of 19 countries of the Americas signaled the region's commitment to harmonizing device regulation with international standards.

The article then did what few had done in English: it laid out, country by country, the actual regulatory pathway for a medtech EFS in Colombia, Mexico, and Brazil. That is the framework this update revisits.

Colombia: the 2022 hotspot, in 2026

In 2022, Colombia was the region's EFS hotspot — fast INVIMA review, strong hospital infrastructure, and hospital fees far below U.S. levels. The pathway had two sequential steps: first, the institution's research ethics committee (REC) issues an approval letter, usually within 15 to 30 business days from submission; then INVIMA reviews the study, with its medical device committee meeting every 30 days on a published schedule with published dossier deadlines (about 25 days before each meeting). That predictable cadence made INVIMA, in the article's 2022 assessment, the fastest device-trial regulator in Latin America.

The 2022 article also reported that INVIMA had evaluated nearly 70 medical device clinical trials from 2017 to 2022, and that Colombia was updating its 2003-era clinical research regulations to harmonize with international standards — part of a 2022–2031 national plan to build a knowledge economy, supported by a Standards Alliance (USAID/ANSI) project with AdvaMed on regulatory efficiency for medical devices.

In 2026, Colombia's core advantage is intact: the monthly committee cadence remains the region's most predictable approval rhythm for device studies. The 2022-vintage timelines and trial counts above describe the framework as it stood — the update is that the framework held, and Colombia's research-incentive conversation continues.

Mexico: the three-step pathway, in 2026

Mexico's 2022 framework ran in three sequential steps. First, a favorable decision from the institution's research ethics committee (REC) and research committee (RC) — usually within 30 business days of filing, up to 60 in public hospitals — with CONBIOÉTICA certifying the REC and COFEPRIS certifying the RC. Second, the institution director's authorization letter. Third, COFEPRIS review and approval: federal law required a decision within 90 days of filing, while industry experts interviewed for the article put actual review times at 45 to 60 days, and COFEPRIS had promised to shorten processing from 90 to 30 days. All 2022 vintage.

The 2022 article's forward-looking case for Mexico rested on three pillars: ICH membership (November 2021 — the fourth country in the Americas, the first Spanish-speaking nation), proximity to the U.S., and scale — over 130 million people and deep public and private hospital infrastructure, with experts estimating the country could reach $800 million per year in clinical trial foreign investment.

In 2026, Mexico's structural case is unchanged — proximity, population, and hospital infrastructure don't expire — and COFEPRIS continues a digitization push aimed at the review timelines the 2022 article flagged. Mexico remains the region's scale play for EFS recruitment.

Brazil: the slowest clock gets a new law

Brazil was the 2022 article's heaviest lift — and its biggest recruitment prize, with nearly 220 million people across 20+ metropolitan areas. The 2022 pathway: foreign-sponsored studies needed CONEP review (15 days for document validation, 45 days for ethical assessment) on top of the institutional CEP (initial report within 30 days), plus WHO/ICTRP registry listing, and only then ANVISA — which by law had 90 calendar days but was actually taking 120 to 180 days, per the Brazilian regulatory expert cited in the article.

The 2022 article's verdict was blunt: Brazil had been slow in reforming its medical device regulations to create a more competitive, agile framework — but its recruitment potential and hospital infrastructure meant sponsors should consider it anyway.

The 2026 update is the reform the article was waiting for. Brazil modernized its clinical research framework under Law 14.874/24, with ANVISA now operating under firm review clocks for device studies rather than the open-ended timelines of the 2022 era. For sponsors, Brazil shifts from “worth it despite the clock” to “worth it with a clock you can plan around.”

New on the 2026 map: Panama and Chile

The 2022 article profiled Colombia, Mexico, and Brazil. Two countries that have since earned their own entries:

• Panama. On April 23, 2026, Panama enacted Decreto Ejecutivo No. 21, implementing Titles III and IV of Ley 84 — accredited ethics committees, the mandatory RESEGIS national registry, statutory review timelines, and codified sponsor duties. Panama's clinical-trial framework went from principles to an operating rulebook.
• Chile. Chile's easy-entry era has an expiration date: a new decree arriving around 2028 will hit high-risk, technically complex products hardest. For EFS work on novel devices, the window to use Chile's current pathway is open but narrowing — accredited comité ético científico review runs 30 to 60 days under the current rules.

The broader 2026 map is covered in our companion update, Latin America's landscape for medtech clinical trials, and in why U.S. companies run first-in-human trials overseas.

Will the FDA accept the data?

The 2022 article summarized FDA's position as two conditions: the study is conducted under good clinical practice, and the agency can validate the data through on-site inspection — with documentation covering investigators, facilities, the protocol, devices, and ethics decisions. The governing regulation, 21 CFR 812.28, frames it the same way in 2026: foreign clinical data is accepted when the study follows GCP with adequate documentation and the data are scientifically valid.

What changed is the context around that acceptance. FDA's Early Feasibility Study program has grown to roughly 60 EFS IDEs per year since FY2017, with more than 4,000 participants enrolled — and the program is moving toward what the agency conversation calls “EFS 2.0”, with EFS IDEs being approved in the first 30-day review cycle and multigeography studies explicitly recognized. The 2026 practice: design the Latin American EFS or FIH for repatriation from day one, so the dataset returns home to support an IDE or Breakthrough Device submission.

Choosing a regulatory pathway in 2026

The 2022 article's country comparison still frames the 2026 decision — updated:

And the decision the 2022 article didn't have to make is now central: U.S. EFS or Latin America FIH? Choose U.S. EFS when early FDA interaction and U.S. site experience matter most. 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.

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