Author: Julio Martinez-Clark

PRACTICAL GUIDE | 2026

US-Funded Research Abroad in 2026: What ‘America First’ Scrutiny Means for LATAM Trials

Most LATAM FIH sponsors can skip this article. If your trial money comes from the US federal government, read it twice.

By Julio G. Martinez-Clark

CEO, bioaccess®

Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.

Publishing package

Key entities, defined plainly. NIH is the US National Institutes of Health — the largest public funder of biomedical research in the world. FIH means first-in-human. LATAM is Latin America. The Uniform Guidance (2 CFR Part 200) is the federal rulebook for grants: it sets the rules for who can receive federal money and under what conditions. A subrecipient carries out part of the funded project and is subject to the award’s compliance terms; a contractor (vendor) simply provides goods or services. A foreign component is project work performed outside the United States that requires NIH prior approval — approval obtained before the work starts. A subaward is funding passed from the prime awardee to a subrecipient. The False Claims Act is the federal law that penalizes false claims for federal money — including mischaracterized grant relationships. A grants counsel is a lawyer who specializes in federal grant compliance.

Who does this post apply to?

A minority of sponsors: those whose LATAM trial work is funded by US federal grants, such as NIH awards. If your FIH program is funded by venture capital, a corporate balance sheet, or any other commercial source, stop here — none of what follows applies to your trial. This distinction matters because most commentary on ‘America First’ research policy gets shared as if it affects everyone. It does not.

What did NIH change in 2025?

Two things sponsors should know at a high level:

• Foreign subaward restrictions. Since 2025, NIH has restricted foreign subawards — funding passed through a US prime awardee to a foreign subrecipient. The policy direction is toward less money flowing abroad through subaward structures.
• Heightened data-access requirements. Foreign subrecipients face heightened requirements around US access to research data — what data must be accessible, where it is stored, and who can review it.

The details are moving. Do not rely on summaries — verify the current position against the live NIH Grants Policy pages before making any decision. This post deliberately cites no notice numbers, because notice numbers go stale and stale citations are worse than none.

What are the operative legal distinctions?

Under the Uniform Guidance (2 CFR Part 200), the questions that determine your obligations are:

That last point is the one sponsors get wrong most often — which is the subject of the next section.

What is the wrong takeaway?

US-Funded Research Abroad in 2026: What ‘America First’ Scrutiny Means for LATAM Trials narrows to this: the legal line runs through the nature of the relationship and the location of the work — never through the payment plumbing. Any structure built on the opposite assumption is built on sand.

What should a grant-funded sponsor do next?

Three steps — and a hard boundary:

1. Classify the relationship honestly. Is the LATAM party a subrecipient or a contractor under 2 CFR Part 200? Get the classification right before the budget is built.
2. Determine foreign-component status. Does the LATAM work require NIH prior approval? Answer this before the work starts — prior means prior.
3. Verify against live policy. Check the current NIH Grants Policy pages. 2025-era restrictions are the starting point, not necessarily the current position.

Frequently asked questions

Does any of this apply to my commercially funded FIH trial?

No. These rules govern US federally funded research. Commercially funded trials — the vast majority of FIH programs — are unaffected.

Can I avoid the foreign-component characterization by routing payment through a US CRO?

No. The characterization turns on the substance of who performs the work and where, not on how many entities sit in the payment chain. Adding a US middleman does not eliminate it.

What is a ‘foreign component’?

Project work performed outside the United States under a federal award. It generally requires NIH prior approval — approval obtained before the work begins.

Why does subrecipient vs. contractor matter?

A subrecipient inherits the award’s compliance, audit, and reporting obligations under 2 CFR Part 200; a contractor does not. Misclassification creates audit exposure.

Where do I verify the current NIH position?

The live NIH Grants Policy pages. This area is moving — treat 2025 restrictions as the starting point and verify before acting.

Can bioaccess® help with grant-funded LATAM work?

Operationally, yes — sites, investigators, regulatory filings, and study execution. But structural and legal questions about the award belong to qualified grants counsel.

For the minority of sponsors working with federal money, US-Funded Research Abroad in 2026: What ‘America First’ Scrutiny Means for LATAM Trials is a map of where the real questions live: the relationship classification, the foreign-component determination, and live NIH policy. Everything else — especially payment-chain engineering — is a distraction from those three.

References

• NIH Grants Policy Statement and NIH Grants Policy pages (verify current foreign-subaward and data-access provisions).
• Uniform Guidance, 2 CFR Part 200 (subrecipient vs. contractor; foreign component; prior approval).

PRACTICAL GUIDE | 2026

Mexico's COFEPRIS Reset: What Faster Approvals Mean for FIH Sponsors

Mexico is rewriting its regulatory timelines. Here is what actually changed, which clocks an FIH sponsor must track, and what to verify before filing.

By Julio G. Martinez-Clark

CEO, bioaccess®

Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.

Publishing package

COFEPRIS (Comisión Federal para la Protección contra Riesgos Sanitarios) is Mexico’s federal health regulator. FIH means first-in-human — the first time an investigational product is given to people. CONBIOÉTICA (Comisión Nacional de Bioética) is Mexico’s National Bioethics Commission. For context: FDA is the United States Food and Drug Administration, EMA is the European Medicines Agency, MHRA is the United Kingdom’s Medicines and Healthcare products Regulatory Agency, TGA is Australia’s Therapeutic Goods Administration, and MDSAP is the Medical Device Single Audit Program.

What actually changed at COFEPRIS?

Five developments, all within the last eighteen months, are reshaping how Mexico handles clinical research and medical-device approvals:

• New commissioner. Víctor Hugo Borja took office as Federal Commissioner of COFEPRIS in January 2026 (publicly reported), bringing new leadership to the agency.
• A presidential-level mandate. The May 2025 Plan México announcement cut clinical-research protocol review from 115 days to 40 days, with a stated goal of reaching two weeks. In 2026, Health Minister David Kershenobich publicly stated a reduction in clinical-trial authorization timelines from roughly 120 days to about 30 days. Treat the 30-day figure as a reported target and political commitment, not an established average.
• Legal reform. A January 15, 2026 decree amended Mexico’s General Health Law (Ley General de Salud), driving clinical-research reform, with COFEPRIS–CONBIOÉTICA coordination on implementation.
• Regulatory reliance. A Regulatory Reliance agreement recognizes evaluations by FDA, EMA, MHRA, and Health Canada to expedite clinical-research protocols — Mexico now leans on work already done by major regulators instead of re-reviewing everything.
• Broad simplification. COFEPRIS procedures were cut from 340 to 125, requirements were halved, and resolution times were reduced from 100 days to 24 days across the agency.

There is also an abbreviated drug pathway, in force since September 1, 2025, that gives decisions in 45 business days for medicines already authorized by FDA or EMA. The trend is the same everywhere in the agency: fewer steps, shorter clocks, and recognition of trusted foreign evaluations.

What are the three clocks an FIH sponsor must track?

Sponsors routinely mix these up. Keep them separate:

Does Mexico re-enter the fast-country conversation?

For years, Mexico sat in the slow lane of our planning: six to nine months from filing to first patient in. If the reported ~30-day protocol review holds in practice, and ethics runs its ~4–6 weeks in parallel rather than sequentially, Mexico moves meaningfully closer to the fast corridor we have long associated with Panama, Chile, El Salvador, and Costa Rica.

That is the opportunity in Mexico’s COFEPRIS Reset: What Faster Approvals Mean for FIH Sponsors — a major market with deep investigator infrastructure and large patient populations, now paired with review timelines that no longer disqualify it on speed. It is not the same as proven speed. Until sponsors and CROs have filed and measured real-world clocks across several submissions, Mexico belongs on the watchlist with an asterisk, not in the fast corridor by default.

What should FIH sponsors verify before filing in Mexico?

Run this checklist on filing day, not at the strategy stage:

1. Current COFEPRIS protocol-authorization timeline. Ask for the current published clock and recent measured performance — not the 2026 announcement.
2. Abbreviated-pathway eligibility for the exact product. Confirm the device holds prior authorization from a recognized authority within the past 5 years and that the product class qualifies.
3. Registration validity. Confirm the 10-year validity period under the 2026 health-law updates is in force for your product on the abbreviated pathway.
4. Ethics pathway and CONBIOÉTICA coordination. Map the committee route, meeting cadence, and any national bioethics requirements before modeling the startup clock.
5. Parallel submission strategy. Confirm that ethics committee and regulator submissions can run in parallel for your study type — the biggest timeline accelerator available.
6. Import mechanics. Fold the investigational-product import permit into the startup clock; a fast protocol authorization means nothing if product is stuck at the border.
7. Local representation. Mexico requires local registration-holder mechanics for device registration — arrange the holder before filing, not after.

Frequently asked questions

Did COFEPRIS really cut clinical-trial approvals from 120 days to 30?

Health Minister David Kershenobich publicly stated a 120-to-30-day reduction in clinical-trial authorization timelines in 2026. Treat it as a reported target and political commitment, not an established average. Verify the current clock on filing day.

What is the abbreviated device pathway?

In force since September 1, 2025: decisions in about 30 business days for medical devices already authorized (within the past 5 years) by FDA, EMA, Health Canada, TGA, or MDSAP. It replaces the standard 3–5-month route, and 2026 health-law updates extended registration validity to 10 years on this pathway.

How long does ethics review take in Mexico?

The working benchmark is ~4–6 weeks — a separate clock from COFEPRIS protocol authorization, running on committee cadence.

Who runs COFEPRIS now?

Víctor Hugo Borja became Federal Commissioner of COFEPRIS in January 2026 (publicly reported).

Will FDA accept data from an FIH trial run in Mexico?

FDA accepts ICH-GCP-compliant data from qualified sites — it does not require a US or EU postal code. What matters is GCP compliance, a trained IRB, and qualified investigators and staff.

Is Mexico now as fast as Panama or Chile?

Not proven yet. If the announced timelines hold in practice, Mexico becomes competitive. Until measured clocks exist across several filings, model Mexico with an asterisk — and parallelize ethics and regulator submissions.

Mexico’s COFEPRIS Reset: What Faster Approvals Mean for FIH Sponsors, in one sentence: a major market with new leadership, reliance on trusted foreign evaluations, and dramatically shorter announced clocks — worth a serious look for FIH programs, with verification built into the plan.

References

• COFEPRIS official announcements and communiqués (2025–2026).
• mexicobusiness.news coverage of COFEPRIS leadership and timeline reforms.
• Plan México announcement, May 2025 (clinical-research protocol review 115 → 40 days).
• January 15, 2026 decree amending the Ley General de Salud (clinical-research reform; COFEPRIS–CONBIOÉTICA coordination).
• COFEPRIS Regulatory Reliance agreement (FDA, EMA, MHRA, Health Canada) for clinical-research protocols.
• Abbreviated pathway in force September 1, 2025 (~30 business days for devices with qualifying prior authorizations).

PRACTICAL GUIDE | 2026

Assemble the core once. Layer the deltas.

By Julio G. Martinez-Clark

CEO, bioaccess®

Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.

Sponsors ask us: “What paperwork is required to submit in each of the countries you are considering?” The answer surprises them. The universal LATAM FIH submission package is nearly the same everywhere. Learn the core once; the country differences are add-ons, not new packages. This checklist exists to prevent the most common filing stalls — the ones that come from assembling documents country by country instead of core-first.

• bioaccess® — a first-in-human (FIH) contract research organization (CRO) running early-stage clinical trials across Latin America.
• FIH (first-in-human) — the first clinical use of a device or drug in people — typically a small, closely monitored early-feasibility study.
• IB (investigator's brochure) — the compilation of everything known about the investigational product: preclinical data, prior human experience, and risks.
• ICF (informed consent form) — the document — and the process — through which a patient is informed about the trial and agrees to participate.
• CRF (case report form) — the structured instrument used to capture every data point for every patient, consistently, at every site.
• INVIMA — Colombia's national institute for food and drug surveillance — the country's medical device and clinical trial regulator.

What documents does every LATAM regulator ask for?

The core package, in every market: the study protocol, the investigator's brochure, the informed consent form, the case report form, the insurance policy, and the preclinical testing package. Six documents. Every regulator asks for them, and the differences between countries sit on top of this core — they do not replace it.

What goes into each document?

• Study protocol — the complete scientific and operational plan: objectives, design, population, procedures, endpoints, statistics, and safety provisions. Everything else in the package must match it.
• Investigator's brochure (IB) — everything known about the investigational product — preclinical data, any prior human experience, known and anticipated risks. This is the document the ethics committee reads most closely.
• Informed consent form (ICF) — what the patient is told and agrees to, written in language the local ethics committee will approve — not just translated, but adapted.
• Case report form (CRF) — how every data point will be captured, consistently, at every site. Lock it before site training; changes mid-study are expensive.
• Insurance policy — coverage for trial-related injury, in the specific form each market requires. The requirement is universal; the paperwork details are local.
• Preclinical testing — the evidence package supporting first use in humans. The standard is the burden-of-proof rule: regulators want proof the product will be safe in humans, not a fixed checklist — rationale can substitute for specific tests.

What changes from country to country?

Local add-ons — and they are genuinely minor next to the core. The clearest example is Colombia: INVIMA expects a risk analysis matrix, and here is the point sponsors ask us to confirm explicitly: the matrix relates to the procedure, not the product. It is an analysis of procedural risk, not a demand for design-verification evidence in the FDA sense. Know the delta; do not rebuild the core. Translations, legalizations, and market-specific forms complete the country layer.

The pre-submission checklist

• Freeze the protocol version before assembling anything else — every document must match it.
• Confirm the investigator's brochure reflects the current preclinical package.
• Draft the informed consent for the local ethics committee's expectations, not just from the template.
• Lock the case report form before site training.
• Verify the insurance policy meets each target market's specific requirements.
• Confirm the preclinical package tells one coherent safety story — the burden of proof is on the sponsor.
• Layer the country add-ons last: Colombia's procedure-risk matrix, translations, legalizations, local forms.
• Reconcile names, versions, and dates across all six documents before submission.

Frequently asked questions

Is the submission package really the same in every Latin American country?

The core is: protocol, investigator's brochure, informed consent, CRF, insurance policy, preclinical testing. Country differences are add-ons layered on that core — for example, Colombia's procedure-risk matrix.

What is Colombia's procedure-risk matrix?

A risk analysis INVIMA expects with the submission — and the confirmed point sponsors ask about: it relates to the procedure, not the product. It is not a demand for design-verification evidence in the FDA sense.

What stalls filings most often?

The preventable ones: an incomplete core package, version mismatches between the protocol, the brochure, and the consent form, and insurance paperwork that does not match local requirements. The checklist above exists to kill all three.

When should we start assembling the package?

Before country selection is final. The six-document core is country-independent, so early assembly shortens every downstream clock.

Do we need the full package before a CRO can quote the study?

A synopsis plus the schedule of events gets you an honest rough range; the full package gets you precision. Quoting from less than that is fiction.

Does the ethics committee want the same package as the regulator?

Substantially yes — and in fast markets both receive it in parallel. Assemble once, submit twice.

Assemble the core once — correctly

bioaccess® builds FIH submission packages for Latin America every week: the universal six-document core, reconciled and version-locked, with each market's add-ons layered on top. Bring us your protocol; we will tell you exactly what is missing.

Talk with bioaccess® about your Latin America FIH strategyTalk with bioaccess® about your Latin America FIH strategy

References

• Core package contents reflect bioaccess® submission practice and sponsor Q&A, 2021–2026 (all clients anonymized).
• Colombia procedure-risk matrix: confirmed as procedure-related, not product design-verification evidence.
• Related reading: “How to Navigate the INVIMA Clinical Trial Submission Process” (bioaccessla.com blog).
• General: confirm market-specific add-ons with qualified regulatory counsel before filing.

PRACTICAL GUIDE | 2026

Enrollment plans built from site flow, not headlines.

By Julio G. Martinez-Clark

CEO, bioaccess®

Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.

Sponsors model recruitment from population statistics. We model it from the clinic's waiting room. Patient recruitment for FIH trials in Latin America is a feasibility exercise, not a demographics exercise — and the feasibility numbers look different from the headlines. These are the planning figures behind the enrollment models we defend to sponsor boards, drawn from client questions we have answered since 2021.

• bioaccess® — a first-in-human (FIH) contract research organization (CRO) running early-stage clinical trials across Latin America.
• FIH (first-in-human) — the first clinical use of a device or drug in people — typically a small, closely monitored early-feasibility study.
• KOL (key opinion leader) — a recognized clinical expert whose practice, referrals, and reputation drive patient flow for a trial.
• First patient in (FPI) — the enrollment of the first trial participant — the milestone that starts the enrollment clock.
• Inclusion/exclusion criteria — the protocol's rules defining exactly which patients may and may not enroll.

How is enrollment actually modeled?

From actual site patient flow — the number of eligible patients the investigator sees per month — not from the country's population or the disease's prevalence. Investigator interest beats demographics: a motivated investigator with a real referral network in a mid-size city out-enrolls a disengaged department in a capital. The planning figures below come from questions sponsors have asked us across calls and email since 2021.

Why is the planning rate only about one patient per month?

First-in-human inclusion and exclusion criteria are narrow by design. The eligible patient is a subset of a subset: the right diagnosis, the right anatomy, the right stage — and willing to consent to an experimental device or drug. One patient per month is the conservative planning figure we will defend to a board. Actual enrollment often runs faster, but budgets and timelines should be built on the number we can stand behind, not the number we hope for.

Does investigator interest really beat demographics?

Yes. When sponsors ask how easy it is to find another bolus of patients mid-study, the answer has three parts: it depends on the investigator, the inclusion/exclusion criteria, and the healthcare system — in that order. The investigator comes first. There is also a structural factor no population table captures: in countries where public-system access is poor, patients are forced to look for trials. Clinical research becomes a genuine care pathway, not a last resort — a real enrollment dynamic, and one more reason patient recruitment for FIH trials in Latin America rewards on-the-ground feasibility over desk research.

What happens when enrollment stalls?

Our job is to recruit patients. We meet with the site every week, find the roadblock, and clear it. Sometimes the roadblock is clinical — referral patterns, screening failures. Sometimes it is logistical — including the US proctor's schedule, which has to align with the procedure date. Weekly management is the difference between an enrollment plan and an enrollment result.

The feasibility checklist: what we confirm before quoting enrollment

• Actual patient flow at the specific site — not national prevalence figures.
• The investigator's demonstrated interest and referral network.
• KOL qualification completed (1–3 months) before activation planning begins.
• Inclusion/exclusion criteria tested against real patient charts, where possible.
• Backup sites prequalified before first patient in — activation becomes a decision, not a project.
• Proctoring schedules aligned with the procedure calendar.
• A weekly recruitment-management rhythm with named owners on both sides.

Frequently asked questions

How long does it take to qualify KOLs in the chosen country?

One to three months: identifying candidate investigators, vetting their practice and patient flow, and confirming genuine interest in the study.

When should we expect the first inpatient?

About one month after regulatory approval — approval in hand, site activated, first patient enrolled.

What enrollment rate should we plan for?

Conservatively, about one patient per month. FIH criteria are narrow by design; plan on the number we can defend, not the number we hope for.

If we need another bolus of patients mid-study, how easy is it?

It depends on three things, in order: the investigator, the inclusion/exclusion criteria, and the healthcare system. That is why backup sites are prequalified up front.

Why would poor public-system access help recruitment?

Because it forces patients to look for trials — clinical research becomes a real care pathway. Sponsors should treat these patients with the same ethical rigor as any trial population; the point is about access dynamics, not about lowering standards.

Do you manage the US proctor's schedule as part of recruitment?

Yes. Proctor scheduling is part of weekly recruitment management — a misaligned proctor is a stalled enrollment, and we treat it as our roadblock to clear.

Build your enrollment model on real site flow

bioaccess® qualifies investigators, models enrollment from actual patient flow, prequalifies backup sites, and manages recruitment weekly — across Latin America. Bring us your protocol; we will tell you what the feasibility numbers actually look like.

Talk with bioaccess® about your Latin America FIH strategyTalk with bioaccess® about your Latin America FIH strategy

References

• Planning figures in this post reflect bioaccess® client programs and sponsor Q&A, 2021–2026 (all clients anonymized).
• Related reading: “Patient Recruitment Strategies in Chile for Clinical Trials Success” (bioaccessla.com blog) — a Chile-specific companion to this LATAM-wide FIH framing.
• General: confirm enrollment planning assumptions against the final protocol and the qualified sites before committing timelines.

PRACTICAL GUIDE | 2026

When the fastest regulatory answer is that there is no registration to file.

By Julio G. Martinez-Clark

CEO, bioaccess®

Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.

A manufacturer from India asked us about Belize. They wanted a registration strategy, a local representative, a timeline. Julio's answer was one sentence: “Belize — you don't need us here.” There is no medical device registration system in Belize. That answer surprised them, and it surprises most sponsors, because the default assumption is that every market requires a registration. It does not. The Latin American countries where you don't need a medical device registration are a small but real part of the map — and knowing which is which saves months and real money.

• bioaccess® — a first-in-human (FIH) contract research organization (CRO) running early-stage clinical trials across Latin America.
• FIH (first-in-human) — the first clinical use of a device or drug in people — typically a small, closely monitored early-feasibility study.
• Registration holder — the legal entity named on a medical device registration, responsible to the regulator for the product on that market.
• Importer of record (IOR) — the entity legally responsible for importing a product — distinct from the registration holder in most markets, identical in Panama's single-importer model.
• Reliance — a regulator's use of another trusted authority's decision — for example, a CE mark — instead of conducting a full local review.
• CE marking — the European conformity marking showing a device meets EU Medical Device Regulation requirements; widely used as reliance evidence outside Europe.
• ISO 13485 — the international quality-management-system standard for medical device manufacturers.

Do I need a medical device registration in Belize?

No. Belize has no medical device registration system. Clearance is reliance-based: CE marking plus ISO 13485 certification, processed through a simple import permit. The practical result is a one-to-four-week clearance with no dossier filing and no dossier fees. That is the whole pathway. For a manufacturer that only needs product in the country — a clinical trial shipment, a distributor's first order — the answer is refreshingly simple, and it is the clearest example of the Latin American countries where you don't need a medical device registration.

Who holds the registration in Panama?

In Panama, the Registro Sanitario must be held by a locally licensed Panamanian entity that is also the importer of record. This is the single-importer model: the holder and the importer are the same local company, and the foreign manufacturer cannot hold the registration directly. Your partner structure in Panama is therefore a regulatory decision, not just a commercial one — the registration lives with the holder, so choose that entity as carefully as you would choose a distributor.

Can the manufacturer hold the registration directly?

In Colombia, yes. Colombia is the Latin American exception: the manufacturer can hold the sanitary registration directly with INVIMA (Colombia's national food and drug surveillance institute), with no local registration-holder entity standing between the manufacturer and the regulator. Julio's operating rule follows from this: file and hold the registration in the manufacturer's name so the sponsor keeps control and can rotate distributors without re-registering. In Brazil, Mexico, and Chile, the practical answer is different — bioaccess® engages a local company to act as registration holder on the manufacturer's behalf.

The registration-holder map

When the honest answer is “don't hire us”

The Latin American countries where you don't need a medical device registration are also a test of honesty. If your only question is how to clear a CE-marked device into Belize, you do not need a registration consultant — you need a correct import permit and clean shipping paperwork. We will tell you that directly. The sponsors who trust us most are the ones we have talked out of work they did not need.

A practical market-entry checklist

• Confirm whether the market has a device registration system at all — before building any dossier.
• If it is import-permit-only, confirm the reliance basis (CE marking + ISO 13485) and the real permit timeline — Belize runs about 1–4 weeks.
• If registration is required, confirm who may legally hold it: Panama requires a local licensed entity that is also the importer of record; Colombia allows the manufacturer directly; Brazil, Mexico, and Chile use an engaged local holder.
• Hold the registration in the manufacturer's name wherever the rules allow, so distributors can be rotated.
• Confirm import mechanics and the importer of record before quoting any timeline to your board — formal, traceable importation is required; hand-carry is at most a limited bridge, never the plan.

Frequently asked questions

Do I need a medical device registration in Belize?

No. Belize has no device registration system. Clearance is reliance-based — CE marking plus ISO 13485 certification — through a simple import permit, in about one to four weeks, with no dossier fees.

Does my CE mark work as a registration across Latin America?

No. Reliance is a pathway some markets offer; it is not a regional rule. In markets with a registration system — Colombia, Brazil, Mexico, Argentina, Chile, Panama, Peru — you still register. The CE mark supports the filing; it does not replace it.

Who can hold a device registration in Panama?

A locally licensed Panamanian entity that is also the importer of record — the single-importer model. The foreign manufacturer cannot hold it directly.

Where can the manufacturer hold the registration directly?

Colombia is the Latin American exception: the manufacturer can hold the sanitary registration directly with INVIMA.

If no registration is needed, is there anything left to get wrong?

Yes — the import paperwork. Formal, traceable importation is still required, and the permit must be filed correctly. Hand-carry is at most a limited bridge, never the plan.

How do I know whether a small market is import-permit-only?

Check with the national authority before assuming anything. The map is counterintuitive, which is exactly why the question is worth asking before you budget for a registration you may not need.

Map your registration strategy before you spend on it

bioaccess® helps medical device companies determine where registration is required, who must hold it, and where an import permit is the entire pathway — across Latin America, from Belize to Brazil. If the answer is that you don't need us, we will say so.

Talk with bioaccess® about your Latin America FIH strategyTalk with bioaccess® about your Latin America FIH strategy

References

• Belize: Ministry of Health and Wellness — medical device import-permit pathway (confirm current requirements before acting).
• Panama: Ministry of Health — Registro Sanitario, single-importer model (confirm current rules before acting).
• Colombia: INVIMA — manufacturer-held sanitary registration.
• Brazil, Mexico, Chile: registration held via an engaged local company acting on the manufacturer's behalf.
• General: agency rules change frequently; confirm the strategy with qualified regulatory counsel.

PRACTICAL GUIDE | 2026

From signed contract to first patient: realistic clocks for the fast corridor and the major markets.

By Julio G. Martinez-Clark

CEO, bioaccess®

Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.

How long does it take to start a first-in-human trial in Latin America? It is the most-asked timeline question in FIH vendor selection — and the honest answer is that there is no single clock. Sponsors ask three versions of it: “What is your quote for the start-up duration?” “What country do you propose for the quickest completion of the FIH study and data quality?” And “How can we speed up the timeline?” This post answers all three with the clocks we actually quote.

How long does it take to start a first-in-human trial in Latin America? The country-by-country clock

Latin America splits into two speed tiers. The fast corridor — Panama, Chile, El Salvador, and Costa Rica — activates in 15 to 45 days. The major markets — Mexico, Brazil, Colombia, and Argentina — typically need 6 to 9 months. Quote by pathway, not by continent.

What drives the startup clock? Four stages

Every country’s clock is the sum of the same four stages. The fast corridor is fast because each stage compresses — not because any stage is skipped.

• 1. Preparation and translation. Protocol, investigator’s brochure, informed consent, case report forms, insurance policy. The quality of the source documents sets the pace — a clean package translates and submits once.
• 2. Ethics committee cadence. How often the committee meets, and whether review runs through a hospital committee or a national body. Panama issues the ethics-submission ID in about 3 business days, with up to 30 days for requirements that rarely arrive.
• 3. Import permits. The investigational device must enter the country through formal, traceable importation. Import timelines fold into the startup clock — plan them as part of the pathway, not after it.
• 4. Parallel vs. sequential submission. In fast markets, the ethics committee and the regulator receive submissions in parallel, not one after the other. Parallel submission is a designed-in timeline accelerator, not a shortcut.

How can you speed up the timeline?

• Activate multi-site — ideally multi-country. Parallel programs in two countries hedge both timeline and recruitment risk; it is the single most effective accelerator.
• Run ethics and regulatory submissions in parallel wherever the pathway allows it.
• Submit a complete, translation-ready package the first time. Most startup delay is rework, not review.
• Pre-qualify KOLs during startup so investigator contracting does not gate first-patient-in.
• Use a CRO that has run the exact pathway before — unfamiliar teams generate the “requirements” that stall everyone else.

From activation to first patient: KOL qualification and enrollment modeling

KOL qualification — identifying, evaluating, and contracting the investigators who will actually enroll — takes 1 to 3 months and can run in parallel with regulatory startup. After approvals land, the first patient typically follows in about a month. For enrollment modeling, we are deliberately conservative: about 1 patient per month for a first-in-human, adjusted to the site’s real patient flow. Recruitment is managed weekly — site meetings every week, roadblocks cleared continuously, backup sites prequalified before they are needed.

Frequently asked questions

Q: Which Latin American country is fastest for a first-in-human trial?

A: Panama, Chile, El Salvador, and Costa Rica form the fast corridor at 15–45 days to activation. Panama is the documented extreme: about 15 days in a real program.

Q: Can you really have a trial activated in 30 days?

A: In the fast corridor, yes. The ethics-submission ID arrives in about 3 business days; requirements, when they come at all, rarely add meaningful time.

Q: What slows startup down in Brazil or Mexico?

A: Full agency review (ANVISA, COFEPRIS) plus ethics committee processes, larger dossiers, and import logistics. The trade-off is scale: deeper investigator pools and larger patient populations.

Q: Do ethics committee and regulator review happen at the same time?

A: In fast markets, yes — submissions run in parallel, which is a major reason the corridor is fast. In major markets the sequence is longer; design the pathway country by country.

Q: How long does KOL qualification take?

A: One to three months — and it should run during regulatory startup, not after it, so investigators are contracted when approvals land.

Q: How long does it take to start a first-in-human trial in Latin America if we need the fastest possible path?

A: Pick the fast corridor, activate multi-site (ideally multi-country), submit ethics and regulator in parallel, and pre-qualify KOLs during startup. That combination is how 15-day activations happen.

How long does it take to start a first-in-human trial in Latin America? Anywhere from 15 days to 9 months — and the difference is the country pathway you choose, the parallelism you design in, and the discipline of the submission. Ask for the clock by country, by stage, and in writing.

Talk with bioaccess® about your Latin America FIH strategy

Tell us your device, your patient population, and your target first-patient-in date. We will give you a country-by-country startup clock — prep, ethics, import, and enrollment — before you commit to anything.

Talk with bioaccess® about your Latin America FIH strategy

References

• bioaccess® operational data from first-in-human programs across Latin America, 2021–2026 (activation timelines, ethics cadence, KOL qualification, enrollment modeling). Last verified: September 2026.
• Country regulators referenced: Panama MINSA, Chile ISP, El Salvador, Costa Rica, Colombia INVIMA, Mexico COFEPRIS, Brazil ANVISA, Argentina ANMAT.

PRACTICAL GUIDE | 2026

Pass-throughs, professional fees, and the parts of a proposal you can actually change.

By Julio G. Martinez-Clark

CEO, bioaccess®

Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.

First-in-human (FIH) trial budgets in Latin America are the most-asked commercial question in our practice — and the most misunderstood. Sponsors see a single large number and ask, “Is there flexibility in that, because that’s a lot more than we were expecting to pay?” The honest answer starts with anatomy: a proposal is not one number. It is three buckets, priced from the schedule of events, with very different rules for what moves and what does not.

What does an FIH budget actually buy? The three buckets

Everything is priced from the schedule of events — the visit-by-visit list of what happens to each patient. More visits, more procedures, more complexity: more budget. That is why a precise quote needs the full protocol and schedule of events, while a synopsis alone only supports a rough range.

What are pass-throughs, and how are they audited?

A pass-through is a cost the CRO pays on your behalf and bills back at cost — site and hospital payments, third-party vendor invoices. It is not margin. Sponsors audit pass-throughs against the underlying invoices: the hospital’s bill, the lab’s invoice, the translation receipt. A general and administrative (G&A) charge of roughly 10–20% over third-party costs covers the administration of those pass-throughs — the contracting, payment, reconciliation, and audit trail.

What is negotiable — and what is not?

Negotiable: the CRO’s professional fees. “Flexibility on our CRO professional fees, because that’s what we control,” as our CEO puts it. Scope, staffing model, and fee structure are all discussable. Not negotiable: third-party costs — “the third-party cost is something we don’t control,” though a good CRO influences it through vendor negotiation. And not negotiable: the advance payment. “We need to have an advance payment, otherwise we won’t be able to start — it’s standard in the industry.” Pay-as-you-go sounds attractive; it does not fund site contracting, imports, and startup work that must be paid before enrollment.

Where can you cut without sacrificing time or data quality?

Sponsors ask this constantly: “What areas could we cut in the proposal without sacrificing time and data quality?” Real answers from real programs:

• Right-size statistics, translations, and EDC/data hosting — typically a $40,000–$50,000 cluster. Trim scope and redundancy, not the functions.
• Self-monitoring: in one program the sponsor took monitoring in-house. It was a legitimate cut because the sponsor had the capability — but it only works if you truly do.
• Negotiate site and hospital payments hard at the CTA stage. They are pass-throughs, so every dollar negotiated is a dollar saved.
• Freeze the schedule of events before quoting. Scope creep after the proposal is the most expensive line item of all.
• Question multi-country designs on cost grounds — but keep them when the timeline needs the insurance. Do not cut the thing that protects your critical path.

What does 8 patients in Panama cost?

A recent 8-patient FIH in Panama came in around $300,000, including hospital fees. The hospital fees are a pass-through expense — negotiated at the CTA, billed at cost, auditable against invoices. That number is a reference point, not a price list: patient count, visit structure, procedure complexity, and country all move it. But it shows the shape of a real LATAM FIH budget — and why the three-bucket anatomy matters more than any single number.

Frequently asked questions

Q: Is there flexibility in an FIH proposal?

A: On the CRO’s professional fees, yes — that is what the CRO controls. Third-party costs can be influenced through vendor negotiation but not repriced; the advance payment is standard and non-negotiable.

Q: Can we do pay-as-you-go instead of an advance payment?

A: No. Site contracting, imports, translations, and startup staffing must be paid before enrollment begins. Advance payment is standard in the industry.

Q: What is the G&A charge on a proposal?

A: Roughly 10–20% over third-party costs. It covers administering the pass-throughs — contracting, payment, reconciliation, and the audit trail — not hidden margin.

Q: What can we cut without hurting time or data quality?

A: Right-size stats, translations, and EDC hosting (a ~$40–50k cluster); consider sponsor self-monitoring if you have the capability; negotiate site payments at the CTA; freeze the schedule of events.

Q: What do you need to quote our study accurately?

A: Protocol or synopsis plus the schedule of events and a feasibility questionnaire. The synopsis alone supports a rough range; precision needs the full package.

Q: What does a first-in-human trial budget in Latin America actually buy?

A: Three things: site execution, CRO professional management, and third-party services — all priced from the schedule of events, with pass-throughs audited against invoices.

First-in-human trial budgets in Latin America reward sponsors who read the anatomy, not just the total. Know which bucket each dollar sits in, know what moves and what does not, and cut scope — never quality infrastructure.

Talk with bioaccess® about your Latin America FIH strategy

Send us your synopsis and schedule of events. We will return a three-bucket budget — site, CRO, third-party — with every pass-through auditable, and tell you honestly what can move.

Talk with bioaccess® about your Latin America FIH strategy

References

• bioaccess® proposal and program data from first-in-human studies in Latin America, 2021–2026 (budget structures, pass-through auditing, CTA negotiations). Last verified: September 2026.
• Companion post: “FIH Cost in Panama or El Salvador vs the US: Use Published Clocks, Not Invented Averages” (cost-comparison angle).

PRACTICAL GUIDE | 2026

The most-asked question in offshore FIH — answered with the actual regulation.

By Julio G. Martinez-Clark

CEO, bioaccess®

Last verified: September 2026 | General information only—not legal or regulatory advice. Rules change frequently; confirm the strategy with qualified regulatory counsel.

Will the FDA accept data from a Latin American first-in-human trial? It is the single most-asked question in our offshore FIH practice. Sponsors ask it in nearly identical words on almost every first call: “Do I have to present this data to the FDA?… what approval do I need before doing that?” A US medtech sponsor once told us he feared an IDE rejection of “South American” data outright. Our answer then and now: that is not an issue at all — provided the study is run to the standard FDA actually asks for.

First, the definitions. FIH means first-in-human: the first time a device or drug is tested in people. GCP means good clinical practice — the international quality standard for designing, conducting, recording, and reporting clinical investigations so the data are credible and subjects are protected (ICH E6; ISO 14155 for medical devices). An IDE is a US investigational device exemption, the FDA permission to study a significant-risk device in humans.

What does the FDA actually require for foreign clinical data?

The rule for medical devices is 21 CFR 812.28, “Acceptance of data from clinical investigations conducted outside the United States.” FDA will accept information on an outside-the-US investigation to support an IDE or a device marketing application — a PMA, a 510(k), or a De Novo request — if the investigation was well designed and well conducted and specific conditions are met. The headline condition is a statement that the investigation was conducted in accordance with GCP, defined as a standard for design, conduct, performance, monitoring, auditing, recording, analysis, and reporting that provides assurance the data and results are credible and accurate and that subjects’ rights, safety, and well-being are protected. GCP includes prior and continuing review and approval by an independent ethics committee (IEC) — what US sponsors call an IRB — and documented, freely given informed consent. The sponsor must ensure FDA is able to validate the data, including by on-site inspection if the agency deems it necessary, and must supply supporting information on the investigators, the protocol, and how GCP compliance was achieved.

For drugs and biologics, the parallel rule is 21 CFR 312.120: FDA accepts foreign clinical studies not conducted under a US IND when they meet GCP requirements. The principle is the same across product types.

Does the FDA prefer data from some countries over others?

No. Sponsors sometimes assume FDA quietly discounts data from smaller or less familiar markets — Panama, El Salvador, the Dominican Republic. In practice, FDA has no published preference list and no country-level bar. The review question is always site-level: was this a qualified site, run by a trained investigator under an independent ethics committee, with GCP documentation FDA can audit? FDA’s scrutiny of any foreign dataset is the same wherever it comes from — GCP compliance, verifiability, and applicability of the study population and clinical practice to the United States. Choose countries by speed, cost, recruitment, and investigator quality. Do not choose them for a supposed “data prestige” ranking that does not exist in the regulation.

Do I have to present this data to the FDA?

Not necessarily. Many Latin American FIH studies are run for internal decision-making: prove the concept works in humans, learn how the device behaves, fix the design or the protocol. If the data never enter a US submission, there is no obligation to present them to the FDA. Early FIH data de-risk the FDA path instead: sponsors arrive at a pre-submission meeting or an IDE with real human evidence rather than assumptions. As Julio tells sponsors, “99% of our clients, they use the data” — and he has never seen FDA reject data because of the country where it was generated. Never. Never, never.

How do LATAM/US data splits work in pivotal studies?

When a pivotal program will run partly in Latin America and partly in the United States, the split is negotiated with FDA — it is “not a black-and-white answer.” Sponsors commonly discuss allocations such as 70–30, 80–20, or 50–50 between regions, typically in a pre-submission (Q-sub) meeting before the pivotal protocol is finalized. FDA wants assurance that the data support the US intended-use population, which is why the conversation happens up front, with the full FIH and feasibility record on the table.

The point: the split is a negotiation with FDA, not a dictate. Bring the question early and bring the data.

How do you de-risk FDA acceptance before the study starts?

• Confirm the protocol, monitoring plan, and data management meet ISO 14155 (devices) and ICH-GCP from day one — not as a retrofit before submission.
• Qualify investigators and sites against FDA-inspectable standards: training records, delegation logs, device accountability, source documentation.
• Document independent ethics-committee review and informed consent per GCP as defined in 21 CFR 812.28(a)(1).
• Build the inspectable file from the first patient, not the last. Our companion post, “What FDA Reviewers Actually Open After a LATAM Device FIH: The ISO 14155 Inspectable File,” covers that file’s mechanics; this post covers the acceptance question it serves.
• Consider an FDA pre-submission to align on the FIH study’s role in the IDE, 510(k), De Novo, or PMA strategy — especially before locking a pivotal data split.

Frequently asked questions

Q: Can I use Latin American FIH data in an IDE submission?

A: Yes — 21 CFR 812.28 expressly provides for FDA acceptance of outside-the-US device investigations supporting an IDE, when the study was well designed, GCP-compliant, and the data are credible and verifiable.

Q: What if my LATAM study was not fully GCP-compliant?

A: FDA allows a waiver request under 21 CFR 812.28(c), or a statement explaining the reason for noncompliance plus steps taken to ensure the data are credible and subjects were protected. Treat that as a fallback, not a plan: design for GCP from day one.

Q: Does FDA inspect Latin American sites?

A: FDA may validate foreign data through on-site inspection if it deems it necessary — and the sponsor must ensure that is possible. Build the site file as if an inspection is coming: that is the practical premise of the acceptance rule.

Q: Will FDA accept data from Panama, El Salvador, Colombia, or Brazil specifically?

A: The regulation sets no country-specific bar. FDA has never, to our knowledge, rejected data because of the Latin American country where it was generated. Site qualification and GCP compliance decide.

Q: Is GCP-compliant LATAM data usable in Europe or other regions too?

A: ICH-GCP is the international standard, so a GCP-compliant package is generally usable across regulators — but each region has its own submission rules. Confirm the strategy with regulatory counsel for every target market.

Q: Will the FDA accept data from a Latin American first-in-human trial run at two sites in two countries?

A: Yes, under the same conditions — multi-site, multi-country data are routine. Keep the GCP standard identical across sites and document any country-level differences in ethics or import processes.

Will the FDA accept data from a Latin American first-in-human trial? The evidence says yes — routinely, for years — when sponsors hold the study to the standard FDA wrote into the regulation. Geography is not the risk. Sloppy GCP is.

Talk with bioaccess® about your Latin America FIH strategy

If you are weighing a Latin American first-in-human and want to know how the data would slot into your FDA strategy — IDE, 510(k), De Novo, or PMA — we will walk through it with you before you spend anything.

Talk with bioaccess® about your Latin America FIH strategy

References

• 21 CFR 812.28 — Acceptance of data from clinical investigations conducted outside the United States (medical devices).
• 21 CFR 312.120 — Foreign clinical studies not conducted under an IND (drugs and biologics).
• FDA guidance: “Acceptance of Clinical Data to Support Medical Device Applications and Submissions: Frequently Asked Questions” — https://WWW.FDA.GOV/media/111346/download
• bioaccess® operational experience with LATAM FIH studies and FDA submissions, 2021–2026. Last verified: September 2026.