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:
Distinction
Why it matters
Subrecipient vs. contractor —
A subrecipient performing part of the project inherits the award’s compliance terms, including audit and reporting obligations. A contractor providing goods or services does not. Misclassifying the relationship creates audit exposure.
Foreign component vs. domestic work —
Work performed outside the US under the award may be a ‘foreign component’ requiring NIH prior approval. The characterization turns on where and how the work is performed — not on how the money moves.
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:
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.
Determine foreign-component status. Does the LATAM work require NIH prior approval? Answer this before the work starts — prior means prior.
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).
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:
Clock
What is reported
Status
Clinical-trial protocol review —
~120 days → ~30 days
Announced by the Health Minister in 2026; political commitment, not an established average. Verify on filing day.
Device registration, abbreviated pathway —
~30 business days
In force since September 1, 2025. For devices with prior authorization (within the past 5 years) by FDA, EMA, Health Canada, TGA, or MDSAP. Replaces the standard 3–5-month route. 2026 health-law updates extended registration validity to 10 years on this pathway.
Ethics committee / IRB review —
Depends on committee meeting schedule
A separate clock from the COFEPRIS protocol authorization. Runs on committee cadence, not on the agency’s timeline.
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 in parallel on each committee’s meeting schedule 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:
Current COFEPRIS protocol-authorization timeline. Ask for the current published clock and recent measured performance — not the 2026 announcement.
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.
Registration validity. Confirm the 10-year validity period under the 2026 health-law updates is in force for your product on the abbreviated pathway.
Ethics pathway and CONBIOÉTICA coordination. Map the committee route, meeting cadence, and any national bioethics requirements before modeling the startup clock.
Parallel submission strategy. Confirm that ethics committee and regulator submissions can run in parallel for your study type — the biggest timeline accelerator available.
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.
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?
It depends on each committee’s meeting schedule — a separate clock from COFEPRIS protocol authorization.
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).
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.
Document
What it proves
The stall it prevents
Study protocol
The science and the plan are complete and coherent.
Version drift between documents.
Investigator's brochure
The product's risk profile is fully disclosed.
Ethics committee rounds of questions.
Informed consent form
Patients are properly informed, in locally approvable language.
Committee rejection of a translated-but-unadapted form.
Case report form
Data will be captured consistently at every site.
Mid-study CRF changes and dirty data.
Insurance policy
Trial-related injury is covered per local requirements.
Regulator hold for non-conforming coverage.
Preclinical testing
First human use is justified by evidence.
Sufficiency challenges at committee review.
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.
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.
Milestone
Planning figure
What it assumes
KOL identification and qualification
1–3 months
Finding and vetting the right investigators in the chosen country.
Approval to first inpatient
About 1 month after approval
Regulatory approval in hand, site activated, first patient enrolled.
Steady-state enrollment
About 1 patient per month (conservative)
FIH-eligible patients under narrow inclusion/exclusion criteria.
Recruitment management cadence
Weekly
Standing meetings with the site to find and clear roadblocks.
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.
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.
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
Market
Who holds the registration
What it means for you
Belize
No registration system — import permit on a reliance basis (CE + ISO 13485)
Clearance in about 1–4 weeks; no dossier fees; no local holder needed.
Panama
Locally licensed Panamanian entity, also the importer of record (single-importer model)
The manufacturer cannot hold it directly; partner selection is a regulatory decision.
Colombia
The manufacturer itself — the LATAM exception
Direct control; distributors can be rotated without re-registering.
Brazil, Mexico, Chile
A local company engaged to act as holder
bioaccess® hires the local holder on the manufacturer's behalf; hold it in the manufacturer's name.
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.
General information, not legal or regulatory advice. Durations marked “bioaccess® experience” are planning estimates from the study timelines (Gantt charts) we have prepared for sponsors. They are not legal deadlines or guaranteed turnarounds. Legal deadlines are cited to the regulation or official page. Every ethics committee and regulator applies its own procedures, so confirm the timeline for your country and site before you commit to a date. Sources last checked: 29 October 2026.
In our recent plans, getting a clinical trial site in Latin America ready for its first patient took about 8 to 9 months from a protocol synopsis, or about 4.5 to 6 months once the full protocol was final, in the countries where ethics and regulatory reviews are quickest. Where the regulator reviews only after the ethics committee has approved, or has a longer clock, add about 1 to 4 months based on the published review clocks, and more if the regulator sends questions.
The phases are industry standard and the same for drug and device trials, so this guide applies to both. Durations can differ where a country has a drug-specific regulator review or a device import or inspection step. Those are flagged in the country notes.
The biggest driver is the final study protocol. The site search can start from a synopsis. Translation, the submission package, insurance and the budget all wait for the final protocol.
What “activated” means. The site has its approvals, signed contract, insurance, product on site and trained staff, and the sponsor has authorized it to enroll patients.
Timeline at a glance
Phase
Illustrative start → finish
1. Protocol (synopsis → final)
Month 0 → 3
2. Site and investigator selection
Month 0 → 3
3–4. Translation and submission package
Month 3 → 4.5
5. Insurance
Month 3 → 4.5
6. Ethics and regulator review (one round of questions)
Month 4.5 → 7
7. Contract and budget
Month 3 → 5
8. Import
Month 4.5 → 7
9. Site initiation → first patient
Month 7 → 9
Illustrative schedule from bioaccess® experience in the quickest-review countries. Overlapping bars run at the same time; protocol changes, country requirements and questions can shift these dates. Where the regulator reviews after the ethics committee, phase 6 stretches by about 1 to 4 months.
Key numbers
8 to 9 months: protocol synopsis to first patient, in our recent plans (quickest-review countries).
4.5 to 6 months: final protocol to first patient, in our recent plans.
30 to 60 days: ethics committee first answer (bioaccess® experience).
About 3 to 6 weeks: what one round of questions added in our plans.
31.4 weeks: average from site identification to completed start-up in a global industry benchmark, not specific to Latin America (Tufts CSDD, 2018).
What you need to send us to start
A protocol synopsis, as early as possible. It lets us start the site and investigator search and the feasibility checks.
The full protocol, with the investigator’s brochure (or, for a device, the instructions for use and a technical summary), the informed consent form and the case report forms. Translation and the submission package start once these are final.
Product documents for the submission, such as manufacturing or quality certificates, specifications and labels. We confirm the exact list for each country.
Insurance: the policy and certificate from your broker, once the site and investigator are known (see below).
Contract and budget decisions: who signs, payment terms, and who acts as importer of record (the local company legally responsible for bringing the product into the country).
The phases, step by step
Phases marked in parallel run at the same time as others. A good plan overlaps everything that can overlap.
#
Phase
What happens
Who does it
Typical duration
1
Protocol: synopsis, then full protocol
The sponsor writes the protocol. We review it for local ethics and regulatory expectations, usually over two review rounds.
Sponsor, with bioaccess® review
Depends on the sponsor. In our recent plans, the protocol took about 2.5 to 3 months from first draft to final, and up to about 4 months until the consent form and brochure were also final.
2
Site and investigator search and selection (in parallel with phase 1, from the synopsis)
We identify candidate investigators, sign confidentiality agreements, send feasibility questionnaires, hold video calls and a pre-study visit, and write a site report for your approval.
bioaccess®, sites; sponsor approves
30 to 45 days to shortlist sites (up to 60 around the holidays). 2 to 3 months including the pre-study visit and signed site report. Plan on the longer figure. (bioaccess® experience)
3
Translation (protocol first)
Translation of the protocol, consent form, investigator’s brochure, case report forms, labels and insurance certificate (certified where the country requires it), then our quality review.
Translators; bioaccess® review
About 4 weeks. In our recent plans, final documents to translated, submission-ready documents took 27 to 35 calendar days; the longer one ran over the year-end holidays. (bioaccess® experience)
4
Submission package (dossier) (overlaps with translation)
Country and site forms, local consent form, investigator CVs and Good Clinical Practice (GCP) certificates, site letters, product certificates, insurance certificate.
bioaccess®, site, sponsor
30 to 45 days once the protocol is final, overlapping with translation. The final assembly itself takes days to about two weeks. (bioaccess® experience)
5
Clinical trial insurance (in parallel)
The broker quotes and binds a policy, local where the country requires it. Insurers usually need the full protocol, the countries, the sites and investigators, and the number of participants.
Sponsor and broker; bioaccess® reviews the certificate
Bound after the site and investigator are chosen. In a recent plan, the policy was issued about 6 weeks after site selection.
6
Ethics committee and regulator review
The ethics committee responsible for the chosen site (in our experience, often the hospital’s own) reviews the study. The regulator reviews at the same time or afterwards, depending on the country (table below). Questions from either one add a response round.
Ethics committee, regulator; bioaccess® manages the answers
30 to 60 days to the committee’s first answer. About 7 to 13 weeks to approval if there is one round of questions. Add the regulator’s time where it comes afterwards. (bioaccess® experience)
7
Contract and budget (in parallel with phases 3 to 6)
The clinical trial agreement and site budget are negotiated with the hospital and signed. Some countries ask for the signed contract inside the submission.
bioaccess®, site, sponsor
About 1 to 2 months, in parallel. (bioaccess® experience)
8
Import of the investigational product (in parallel)
Import permit, shipment, customs clearance and delivery to the site. Some countries also inspect devices before use.
Importer of record, bioaccess®, sponsor
About 5 weeks to 3 months; the longer end is where the authority inspects the device. Start the paperwork early. (bioaccess® experience)
9
Site initiation and activation
Site initiation visit and training, data system access, sponsor activation letter, then first patient. The data system build runs in parallel, well before this step.
Sponsor, monitor, site, bioaccess®
About 1 to 10 weeks, depending on scheduling and on whether the product has cleared import. (bioaccess® experience)
How it adds up (bioaccess® experience, quickest-review countries)
Month 0 to 3: the protocol is finalized (phase 1). Site and investigator selection runs at the same time (phase 2).
Month 3 to 4.5: translation and submission package (phases 3 and 4). Insurance is bound about 6 weeks after the site is chosen (phase 5). Contract and budget negotiation starts (phase 7).
Month 4.5 to 7: ethics and regulatory review, including one round of questions (phase 6). Import runs alongside (phase 8).
Month 7 to 9: site initiation and first patient (phase 9).
One round of questions from the ethics committee or regulator added about 3 to 6 weeks in our plans. Most legal review clocks stop while the sponsor is answering questions, so a “30-day” review can take much longer on the calendar.
Who does what
This is the usual division of work in bioaccess® practice. We confirm filing, signing, import and training responsibilities for each study.
Phase
Sponsor
bioaccess®
Site and investigator
Ethics committee / regulator
Broker / insurer
Protocol
Writes and approves
Reviews for local expectations
Gives feasibility input
Site selection
Approves the site report
Searches, qualifies, visits
Completes feasibility
Translation and submission package
Supplies source documents and product certificates
Translates, reviews, assembles
Supplies CVs, GCP certificates, site letters
Insurance
Buys the policy
Reviews the certificate for local rules
Quotes and issues
Ethics and regulator review
Answers scientific questions
Files and manages answers
Signs as investigator
Reviews and decides
Contract and budget
Approves terms, signs where a party, funds agreed payments
Negotiates
Negotiates and signs
Import
Ships product
Coordinates permits
Receives and stores product
Issues permits where required
Site initiation
Issues the activation letter
Coordinates
Completes training and readiness checks; opens enrollment after sponsor authorization
Country notes: who reviews, and in what order
At a glance. Ethics and regulator at the same time: Brazil (the submissions), and Panama for high-risk research. Shared platform, ethics first: El Salvador. One after the other: Costa Rica, Colombia, Mexico, Peru, Ecuador. Check for your study: Chile, Argentina, Dominican Republic, Guatemala, Uruguay.
What business days mean in practice. 30 business days is about 6 weeks on the calendar, 60 business days about 3 months, and 90 business days about 4 months, before public holidays.
The table shows what public regulations or official pages say. Where we add our own experience, it is marked bioaccess® experience. Committee meeting calendars and real turnaround are practice, and they vary by committee.
Country
Ethics and regulator: same time or one after the other?
Published review clock
Panama
Same time. For high-risk research, the Ministry of Health (MINSA) technical review runs alongside the ethics review, and its findings must be resolved before the committee’s final decision (Executive Decree 21 of 2026, Art. 91).
Registry receipt within 3 business days (Art. 86). Ethics review up to 20 business days for ordinary review and 10 for expedited. If it goes back to the full committee, the total is 30 business days, and the time spent answering questions is not counted (Arts. 44 and 45). Where medicines or health products are used, the National Directorate of Pharmacy and Drugs responds within 15 business days (Art. 95).
El Salvador
One shared SRS–CNEIS platform. The official SRS route lists ethics approval by the national committee (CNEIS) before the regulator’s trial authorization.
Official SRS route: research site registration 20 business days; CNEIS approval 20 business days; SRS trial authorization 20 business days; special import permit 24 to 72 business hours. bioaccess® experience: first responses in about 3.5 to 7 weeks; approval in about 47 days without questions, and 67 to 85 days with one round of questions.
Costa Rica
Accredited ethics committee (CEC) first, then registration with the national council (CONIS).
CONIS acknowledges a complete registration within 5 business days, which registers the protocol provisionally; its technical report is due within 10 business days of assignment (CONIS procedure, 2025). At social security (CCSS) hospitals, research can start 8 days after notice of CONIS registration and delivery of the ethics approval documents (CCSS memo CENDEISSS-AB-0115-2024).
Chile
Drug trials need both a favorable report from an accredited ethics committee and authorization from the regulator, ISP (Exempt Resolution 5161).
InvestChile reports a 45-day term for drug trial authorization and an average evaluation of 28 business days. bioaccess® experience (device study): a notification to the health authority after ethics approval, acknowledged in about 16 days.
Colombia
The ethics committee first, then INVIMA. bioaccess® runs first-in-human studies in Colombia now.
For protocols with investigational medicines, INVIMA gives its first response within 60 business days. The sponsor then has 30 days to reply, and INVIMA decides within 30 days of the reply (INVIMA guide ASS-RSA-GU039 v6, 3.5).
Brazil
Can be submitted at the same time. A drug trial starts only after both approve.
Ethics committee: 10 working days to check completeness, then 30 days from acceptance of the documentation for the opinion (Law 14,874). ANVISA: 90 business days for drug trial dossiers (RDC 945).
Mexico
The institution’s ethics and research committees first, then COFEPRIS.
COFEPRIS: maximum 30 calendar days for protocol authorization (DOF agreement of 28 April 2025).
Argentina
Confirm the ethics steps and their order for your study.
ANMAT, for clinical pharmacology (drug) studies: 20 business days of technical review plus 10 of administrative review for low-risk and special studies, and 35 plus 10 for the rest (Disposition 7516/2025).
Peru
The ethics committee first, then the national institute of health (INS).
INS: up to 30 working days.
Dominican Republic
Review by the national bioethics council (CONABIOS). Confirm whether a regulator review runs alongside for your study.
CONABIOS: final result within 45 business days (21 calendar days for urgent protocols). Submit at least 60 days before the planned start.
Guatemala
Two reviews, an ethics committee and the regulator (DRCPFA), for drugs and devices (Ministerial Agreement 206-2021).
DRCPFA: authorization within 30 business days of complete documentation (Ministerial Agreement 206-2021).
Ecuador
The ethics committee (CEISH) first, then the regulator, ARCSA. Device trials follow the drug procedure until device rules are issued.
ARCSA: document check in 7 days, then up to 60 days for the technical review (extendable by 30). The signed contracts and an insurance policy from an insurer registered in Ecuador are part of the ARCSA file.
Uruguay
Registration with the Ministry of Public Health (MSP), then MSP authorization where it applies. The authorization file includes the protocol and consent form approved by the institutional ethics committee.
Ethics committees: 60 days (Decree 158/019). Confirm the MSP clock with the ministry.
Drugs and devices. The phases are the same for both. The differences are country steps. Chile’s ISP authorization, Brazil’s 90-business-day ANVISA clock, Colombia’s INVIMA clock and Argentina’s ANMAT clock above are the rules for drug trials. Devices may need an extra import or inspection step, as in El Salvador.
Legal clocks vs what actually happens
The country table mixes published review clocks with labeled bioaccess® experience. A review deadline is not an end-to-end activation estimate. Real elapsed time can sit far from the legal clock, in either direction. In some countries the clock stops while the sponsor answers questions, holidays don’t count as business days, and many clocks start only once the file is accepted as complete. Published observed data shows how far real timelines can sit from the legal clocks:
Brazil. In 196 contract-research-managed oncology trials, ANVISA’s mean time to final approval fell from 341 calendar days in 2013 to 90 days in 2023. The national ethics commission (CONEP) fell from 164 to 141 days. For May 2022 to December 2023, the means were 99 days (ANVISA) and 172 days (CONEP) (Giacomazzi et al., JCO Global Oncology, 2026). The study predates the review deadlines of Law 14,874.
Region. A 2026 review reported median trial start-up times of about 2.8 months in Mexico, 4.5 months in Argentina, 4 to 7 months in Brazil, 4.6 months in Chile, 7 months in Colombia and up to 9 months in Peru (Zavaleta-Monestel et al., Cureus, 2026, citing oncology literature). Definitions of “start-up” differ between studies, so treat these as context, not as a plan. They are not comparable with the review order in the country table or with our synopsis-to-first-patient figures.
Industry. The Tufts CSDD benchmark found an average of 31.4 weeks from site identification to completed start-up, with repeat sites 9.9 weeks faster than new ones (Tufts CSDD, 2018).
First site vs all sites. Check whether a benchmark measures one site, the first site activated or all planned sites. In a multicenter study, each site runs its own contract and initiation, and its own ethics approval where no central committee covers it. Plan around the sites you need to meet your recruitment target, not only the first.
What slows activation, and how to prevent it
What slows it
Evidence
How to prevent it
A protocol that keeps changing
76% of protocols in phases 1 to 4 have at least one amendment, with a mean of 3.3 (Tufts CSDD 2024, as cited by IQVIA). A change after translation may mean updated translations and, after submission, an amendment.
Freeze the protocol, consent form and brochure before translation starts.
Questions from the ethics committee or regulator
One round added about 3 to 6 weeks in our plans. Some legal clocks stop while the sponsor answers (Panama Decree 21, Art. 45, for ethics review; Brazil Law 14,874 lets ethics queries suspend the clock for up to 20 business days, as summarized by PSI CRO, 2024).
Answer within days, not weeks. Have the scientific owner on call during review.
A late insurance certificate
In one of our plans, a late policy forced a consent-form update and ethics resubmission, adding about 2 months.
Start the broker as soon as the site and investigator are chosen.
New sites with no track record
Repeat sites were 9.9 weeks faster in the Tufts benchmark.
Prefer sites that have run a similar study.
Site type and start-up capacity
In WCG’s 2025 survey of mostly US sites, 54% of independent sites reported they can start studies in under 60 days, against 9% of academic centers, community hospitals, health systems and site networks (WCG Site Challenges Report 2025).
Ask each site for its contract, budget and ethics calendar at selection.
Contract and budget negotiation
ACRP lists budget negotiations among the common causes of start-up delay, with bureaucracy, training and local approvals (ACRP sponsored article, 2025).
Send the contract template and budget with the feasibility package and negotiate during review.
Import permits and inspections
5 weeks to 3 months in our plans; the longer end when the authority inspects the device.
Name the importer of record early and file as soon as the country allows.
Year-end holidays
In our experience, committees and hospitals slow down; our longest translation ran over the holidays.
Confirm translator availability and committee meeting dates before planning a December submission.
Insurance: why it comes later than sponsors expect
Many countries in the region ask for proof of clinical trial insurance in the ethics or regulatory file, and some ask for a locally issued policy. Our country-by-country insurance guide (linked below) has the details. Insurers and brokers usually won’t issue a policy until they have:
the full protocol (not only the synopsis),
the countries, sites and principal investigators,
the number of participants and the study duration, and
the investigator’s brochure or device information.
So the realistic order is: final protocol → site and investigator selected → insurance quote and policy → certificate translated → ethics submission. If the certificate arrives after the ethics submission, the committee may need a second look. In one of our recent plans, a late policy meant translation, a consent-form update and an ethics resubmission, which added about 2 months.
Use this as a planning checklist, then confirm the required documents and versions for each country, committee and study.
Before site selection (phase 2)
– ☐ Protocol synopsis
– ☐ Target countries and number of sites
– ☐ Confidentiality agreement template
– ☐ Feasibility questionnaire
Translation inputs (phases 1 and 3): schedule each document as soon as its final source version exists
– ☐ Final protocol (version and date)
– ☐ Investigator’s brochure, or device instructions for use and technical summary
– ☐ Informed consent form (master version)
– ☐ Case report forms
– ☐ Product labels
Submission package (phase 4)
– ☐ Country and ethics committee application forms
– ☐ Local-language consent form
– ☐ Investigator CVs and Good Clinical Practice certificates
– ☐ Site letters (acceptance, facilities)
– ☐ Product quality certificates
– ☐ Insurance certificate (phase 5)
– ☐ Signed contract, where the country asks for it (Ecuador, for example)
Before the first patient (phases 7 to 9)
– ☐ Ethics approval and every regulator approval, registration or notice the country requires
– ☐ Signed contract and budget
– ☐ Product imported, released and stored at the site
– ☐ Data system access and training complete
– ☐ Site initiation visit done
– ☐ Sponsor activation letter issued
Glossary
Site activation: the point when a site has its approvals, contract, insurance, product and trained staff, and the sponsor authorizes it to enroll.
Synopsis: a short summary of the study design, used to start feasibility.
Ethics committee (EC): the independent committee that reviews the study for participant protection. Called a CEI, CEC or CEP in some countries.
Regulator: the national health authority (for example ANVISA, COFEPRIS, INVIMA, ANMAT, ISP, MINSA).
Business days: working days, excluding weekends and public holidays.
Importer of record: the entity responsible for the import declaration and import obligations; local eligibility rules apply.
Site initiation visit (SIV): the visit that trains the site team on the protocol before enrollment.
Good Clinical Practice (GCP): the international quality standard for running clinical trials.
Frequently asked questions
Why can’t you quote insurance for us yet?
A broker usually needs the full protocol, the sites, the investigators and the number of participants to give a firm quote. With only a synopsis, that information doesn’t exist yet. In a recent plan, the policy was issued about 6 weeks after the site was chosen.
How long until the first patient?
In our recent plans, about 8 to 9 months from a protocol synopsis in the quickest-review countries, and about 4.5 to 6 months once the protocol was final. Countries where the regulator reviews after the ethics committee, or has a longer clock, add about 1 to 4 months, more if there are questions.
Can the phases run at the same time?
Yes, and they should. Site selection can start from the synopsis. Translation, the submission package, insurance, the contract and the import paperwork overlap. What can’t start early is the review: the ethics committee and the regulator need the final, translated documents. In some countries the two reviews then run at the same time (see the country table).
What makes timelines slip?
In our experience: a protocol that keeps changing, a late insurance certificate, a round of questions from the ethics committee or regulator, and the year-end holidays, when committees and hospitals slow down.
Is this different for drugs and devices?
The phases are the same. Durations can differ where a regulator has a drug-specific review or where a device needs an import or inspection step, as noted in the country notes.
Is there an outside benchmark?
A 2018 Tufts Center for the Study of Drug Development benchmark reported an average of 31.4 weeks from site identification to completed study start-up. Repeat sites took 9.9 weeks less than new ones (Tufts CSDD, 2018). It measures a different span than synopsis to first patient, so treat it as context.
What is the difference between site activation and first patient?
Activation means the site is authorized and ready to enroll. The first patient is a later milestone; define it in your plan (first consent, first enrollment or first treatment). In our plans, the time from site initiation to the first patient ranged from about 1 to 10 weeks.
Do I need a separate ethics approval for every site?
It depends on the country and the hospital. In our experience, some countries use a national or central committee and others require the hospital’s own committee. Brazil’s Law 14,874 introduced a single committee for multicenter studies (as described by Giacomazzi et al., 2026). We confirm this per country and site.
Which country is fastest?
In our recent plans, the quickest pathways were Panama, El Salvador and Chile, where ethics and regulatory approval of a complete submission took about 1 to 3 months. Our Chile figure is from a device study; drug trials there also need ISP authorization. Costa Rica’s published clocks are also short (see the country table). The fastest country for your study also depends on whether its sites can enroll your patients.
What can I do this week to save time?
Send the synopsis so the site search can start. Freeze the protocol before translation. Line up a broker. Decide who will be the importer of record.
Get a timeline for your study
Send us your protocol synopsis and the countries you are considering. We will send back a study-specific Gantt chart with every phase above, who owns it and what can run in parallel. Contact bioaccess®.
Uruguay: gub.uy procedure “Registro / Autorización de proyectos de investigación en seres humanos”.
El Salvador: bioaccess® experience (no official clock cited).
Tufts CSDD press release, 7 March 2018.
bioaccess® study timelines (Gantt charts) for drug and device studies in Panama, El Salvador, Chile and Colombia, 2022 to 2026, de-identified.
Giacomazzi J, et al. “Decade of Progress: Ethical and Regulatory Approval Timelines for Cancer Clinical Trials in Brazil.” JCO Global Oncology 12, e2600138 (2026).
Zavaleta-Monestel E, et al. “Reframing Clinical Research in Latin America: Implications of Underrepresentation for Health Systems and Global Evidence.” Cureus (2026), PMC12959233.
General information, not a quote. Every figure is either an official fee linked to the regulator, or a planning range from bioaccess® budgets and our rate card, marked “bioaccess® experience”. The worked examples are small first-in-human medical device studies run in Costa Rica, El Salvador, Panama or Chile. For drug trials and for complete budgets in other countries, confirm with us. All amounts are in US dollars unless noted. Official fees checked 29 October 2026; bioaccess® figures come from our 2026 budgets.
A first-in-human device study budget in Latin America has three parts: site costs (paid to the hospital and investigator), CRO professional fees (project management, monitoring, regulatory, data, reporting) and third-party costs (insurance, translations, import, couriers, regulator fees). Everything is priced from the protocol’s schedule of events.
In our illustrative samples, a 20-subject minimally invasive device study at one site comes to about $433K to $735K over about 15 months, and a 10-subject surgical implant study to about $839K to $1.32M over about 20 months (bioaccess® experience). The biggest swing is the per-subject site payment, which depends on the procedure. The fixed official fees we list below are small next to these totals. Costa Rica’s levy is different: it is 3% of the total study budget.
Illustrative sample budget totals, US dollars (bioaccess® experience). Not a quote. Excludes the data system licence, the product, core labs, safety committees and taxes.
How a clinical trial budget is built
Part
What it covers
How it is priced
Who controls it
Site costs
Investigator and coordinator time, procedures, hospital and operating room, tests
Per subject and per visit, from the schedule of events
Negotiated with each site; paid at cost and auditable against the site’s invoices
Rate card: per site, per month, per visit or per deliverable
The CRO; this is where scope and fees can move
Third-party costs
Insurance, translations, regulator and ethics fees, import, freight, travel
At cost, with a handling fee
The market; the CRO can negotiate vendors but not reprice them
A handling or administration charge on third-party costs is common. Ask any CRO to show it as a separate line.
The budget, line by line
Ranges are for one site, from the two samples below (bioaccess® experience). Lines and totals are rounded separately, so the lines may not add up exactly to the totals.
#
Line item
What it covers
How it is priced
Sample A: minimally invasive device (20 subjects)
Sample B: surgical implant (10 subjects)
1
Study design review, kick-off and site feasibility
Protocol review, feasibility, pre-study visits
Rate card
about $38K
about $38K
2
Site budget and contract
Negotiating the site budget and agreement
Rate card, per site
$9K–$13K
$9K–$13K
3
Ethics and regulatory submissions, translations, import permit
Dossier, translations, submissions, answers to questions
Ongoing management and remote and on-site oversight
Per site-month
$48K–$65K
$88K–$115K
9
Interim and close-out monitoring visits
On-site visits
Per visit
$14K–$23K
$24K–$34K
10
Safety, status reports and site closure
Safety reporting, status reports, closure
Rate card
$22K–$32K
$22K–$32K
11
Data system build and training
Building the study on the sponsor’s licensed data system
Rate card; licence not included
$16K–$18K
$16K–$18K
12
Medical monitor
Medical oversight through enrollment and follow-up
Monthly retainer
$32K–$38K
$49K–$56K
13
Serious adverse event handling
Processing and reporting each event
Per event
$0–$10.5K for 0–3 events
$0–$10.5K for 0–3 events
14
Clinical study report
Statistical analysis plan, data cleaning, tables and the full report
Per report, by study design and size
$35K–$50K
$35K–$50K
15
Per-subject site payments
Investigator, coordinator, procedures; operating room and facility for implants
Per subject and visit
$52K–$185K
$321K–$604K
16
Site payment management
Paying sites and reconciling invoices
Percentage of site payments
$10K–$37K
$59K–$93K
17
Third-party costs at cost
Insurance, ethics and regulator fees, freight, travel
At cost
$20K–$48K
$20K–$58K
18
Handling on third-party costs
Administering third-party payments
Percentage
$4K–$10K
$4K–$12K
19
Contingency
Reserve for scope changes
Percentage of lines 1–14
$45K–$59K
$57K–$72K
Rates behind the lines(bioaccess® experience; rate card v2026.13, subject to change):
Project management and monitoring: $4,750 per enrolling site-month for minimally invasive device studies and $7,750 for surgical implant studies. Follow-up months are billed at a separate rate.
Medical monitor: $3,500 per month.
Serious adverse events: $3,500 per event.
Site payment management: 20% of the first $250K of site payments and 12% above that.
Other third-party costs: 20% handling.
Contingency: 15% of professional fees (lines 1–14).
Clinical study report: the $35K–$50K range covers a single-arm study of up to 30 subjects at one or two sites. For larger or randomized studies, confirm with us.
Two sample budgets
Sample A: minimally invasive device
Sample B: surgical implant
Subjects and sites
20 subjects, 1 site, 1-month follow-up
10 subjects, 1 site, 6-month follow-up
Duration
about 15 months
about 20 months
Sample total
$433K–$735K
$839K–$1.32M
Costa Rica only: add the 3% levy
$13K–$22K
$25K–$40K
Sample total if run in Costa Rica
$446K–$757K
$864K–$1.36M
Two-site version
about $505K–$865K
about $930K–$1.48M
bioaccess® experience. Illustrative, not a quote.
Assumptions:
Countries: the samples are built for Costa Rica, El Salvador, Panama or Chile. Regulatory start-up in Mexico or Colombia costs more; see below.
Schedule: about 4 months of start-up. Enrollment runs at about 2.5 subjects per site per month (device) or 1.25 (implant), with a 3-month minimum. Follow-up is 1 month (device) or 6 months (implant), then about 2 months of close-out and reporting.
Monitoring and safety: about 30% screen failures; an interim monitoring visit about every 2 active months per site (at least 4); up to three serious adverse events.
Excluded: the data system licence, the product, core labs, independent safety committees, taxes and currency movements.
Full line codes and a month-by-month timeline: sample budget.
What one more month, subject or site adds
bioaccess® experience; rate card v2026.13:
One more enrolling month: another site-month of project management and monitoring ($4,750 device or $7,750 implant per site), another month of the medical monitor ($3,500), and another month of the legal representative and trial master file.
One more subject: another per-subject site payment (about $2K–$11K device or $32K–$60K implant), plus the site payment management percentage.
One more site: another round of feasibility, contracting, ethics submission, initiation, monitoring and closure. A second site shortens enrollment but adds cost; compare the one-site and two-site totals above.
What changes by country
The line items are the same everywhere. These lines change by country:
Line
What changes
Countries where it matters
Regulator and ethics fees
Published fees differ. Costa Rica charges a 3% levy on the whole budget
All; see the fee table
Per-subject site payments
Hospital, operating room and investigator rates
Every country; quote per site
Translations
Spanish in most countries; Portuguese in Brazil
Brazil needs a separate language set
Trial insurance
Local policy or certificate, priced by the insurer
CONIS levy (canon) of 3% of the total study budget, paid when the approved project is registered. The law’s exemptions do not apply to studies sponsored by for-profit organizations. Each accredited ethics committee sets its own review fee.
CNBI, sponsored studies: new protocol B/.1,500 per protocol; amendment B/.800; additional site B/.500 per site; annual renewal B/.800 per site (the balboa trades at par with the US dollar). Institutional committees publish their own fees.
DIGEMID’s import authorization procedure lists no fee. The page shows the online service disabled since 20 August 2026, so confirm the current filing route and fee with us. Freight, broker and duties are separate.
ISP authorization is required for provisional use of an unregistered product. ISP fee and the applicable code: confirm with us. Ethics committee fees vary by committee.
From our 2026 budgets(bioaccess® experience). These are per-subject site payments, the same basis as line 15:
Study type
Per-subject site payment
Minimally invasive device
about $2K–$11K
Surgical implant, including operating room and facility time
about $32K–$60K
By procedure type(bioaccess® experience, de-identified across programs). These are site clinical costs per patient, including site overhead and excluding CRO fees and the product, so the basis differs from the table above:
Procedure type
Per-patient site cost
Ophthalmology, outpatient implant
about $13K
Orthopedics, surgical implant (inpatient)
about $25K–$28K
Peripheral vascular or endovascular, cath lab
about $23K–$38K
Regulatory start-up cost: Mexico and Colombia
bioaccess® experience. Our regulatory start-up-to-approval package starts at about $188K in Mexico and about $305K in Colombia, roughly 1.6 times Mexico. In our experience, Colombia’s package includes an additional INVIMA technical-dossier step. These are package starting points, not a matched-protocol comparison. They exclude the product, trial insurance and the study after approval. For your scope, confirm with us. bioaccess® runs first-in-human studies in Colombia now.
What you can negotiate and what you cannot
Item
Negotiable?
Notes
CRO professional fees
Yes
Scope, staffing and fee structure can be discussed
Third-party vendor costs
Limited
The CRO can negotiate vendors but cannot reprice the market
Site and hospital payments
When the site contract is negotiated
Then paid at cost and auditable against invoices
Advance payment
Usually not
Common in study start-up: contracting, imports and translations are paid before enrollment
Official fees and levies
No
Set by the regulator or the law
Where sponsors can save without hurting time or data quality: freeze the schedule of events before the quote, negotiate site payments at contract stage, and right-size statistics, translations and data hosting. Monitoring, data management and regulatory compliance are poor places to cut in a first-in-human study.
How to compare CRO quotes
Ask
Why
Is every line in the table above included, and which are excluded?
Totals are not comparable if one quote leaves out the site payments or the report
How are site payments and third-party costs marked up?
Handling fees should be visible as lines
How many monitoring months are assumed?
Slow enrollment adds months of fees
What screen-failure rate and enrollment pace are assumed?
They drive the site payments and the duration
Which country fees and levies are included?
Costa Rica’s levy alone is 3% of the total
What triggers a change order?
Amendments, extra visits and longer enrollment change the budget
What is the payment schedule?
An advance payment is common in study start-up
Budget checklist
☐ Final schedule of events sent with the request for a quote
☐ Country and number of sites chosen
☐ Screen-failure rate and enrollment pace agreed
☐ Site payments quoted per visit, including operating room and hospital time
☐ Insurance quote requested
☐ Import route and broker priced
☐ Official fees and levies listed per country
☐ Excluded items listed
☐ Contingency agreed
☐ Change-order triggers and payment schedule agreed
Glossary
Schedule of events: the visit-by-visit list of procedures in the protocol; the basis of every budget.
Pass-through: a cost the CRO pays for the sponsor and bills at cost, auditable against the invoice.
Site-month: one month of activity at one site; the unit for management and monitoring fees.
Screen failure: a person screened who does not enroll.
Contingency: a reserve for changes in scope.
CONIS levy (canon): Costa Rica’s charge of 3% of the total study budget, paid when the approved study is registered.
Importer of record: the local party legally responsible for bringing the product into the country.
Frequently asked questions
How much does a first-in-human medical device trial cost in Latin America?
In our illustrative samples, about $433K to $735K for a 20-subject minimally invasive device study at one site, and about $839K to $1.32M for a 10-subject surgical implant study (bioaccess® experience). Your protocol sets the real number. For drug trials, confirm with us.
Which line moves the budget most?
Per-subject site payments. In our 2026 budgets they ran about $2K to $11K per subject for minimally invasive devices and $32K to $60K for surgical implants, including operating room time (bioaccess® experience).
Which country is cheapest?
It depends on the site, the procedure and the timeline, so compare study-specific budgets. Among the fees we list, the fixed ones are small next to a study total. Costa Rica’s levy is 3% of the total study budget.
Are regulator fees a big part of the budget?
The fixed fees we list are not. For example, Panama’s national bioethics committee charges B/.1,500 for a new protocol, and El Salvador’s regulator charges $2,040 to evaluate a clinical trial project. Costa Rica’s 3% levy grows with the budget.
What do these sample budgets exclude?
The data system licence, the product, core labs, independent safety committees, taxes and currency movements. Confirm inclusions and exclusions in each CRO proposal.
How much does one more month of enrollment cost?
In our samples, another site-month of management and monitoring ($4,750 for device studies or $7,750 for implant studies per site), plus $3,500 for the medical monitor and another month of the legal representative and trial master file (bioaccess® experience).
Is this a quote?
No. The figures are illustrative planning ranges and official fees. We prepare a budget for each study.
Get a budget for your study
Send us your synopsis and schedule of events. We will return a line-by-line budget by country. Contact bioaccess®.
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.
Split model
Typical shape
When sponsors use it
LATAM-heavy (70–30)
Most enrollment in Latin America; US cohort confirms generalizability
FIH and feasibility already completed in LATAM; device is stable
Balanced (50–50)
Roughly equal enrollment
Sponsor wants parallel recruitment and a single global dataset
US-heavy (80–20)
Most enrollment in the US; LATAM sites add speed and diversity
Sponsor plans a US-led IDE with regional acceleration
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.
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.
First-in-Human for Biopharma in Latin America: Phase 1, Healthy Volunteers, and Bioanalytical Lab Selection
For biopharma FIH, the study is only half the question. The other half is who runs the assays — and whether regulators will accept the data.
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. FIH means first-in-human — the first time a drug is given to people. Phase 1 is the first clinical stage, usually in healthy volunteers (HV). A bioanalytical lab measures drug concentrations (PK, pharmacokinetics), effects (PD, pharmacodynamics), immune responses (ADA, anti-drug antibodies), and biomarkers in study samples. GCP (Good Clinical Practice) governs clinical studies; GCLP (Good Clinical Laboratory Practice) applies GCP principles to labs that analyze clinical samples; GLP (Good Laboratory Practice) governs nonclinical studies. ICH M10 is the international guideline for bioanalytical method validation and study-sample analysis. LC-MS/MS (liquid chromatography–tandem mass spectrometry) and LBA (ligand-binding assay) are the two main analytical platforms. INVIMA is Colombia’s regulator, ANMAT is Argentina’s, and ANVISA is Brazil’s. B/BE means bioavailability/bioequivalence; ISO 17025 is a laboratory competence standard; SLA is a service-level agreement on turnaround time.
Why does bioanalytical lab selection start before first patient in?
In a device FIH, the data product is the clinical outcome. In a biopharma FIH, the data product is the assay result — PK curves, ADA incidence, biomarker movement. If the lab is wrong, the study is wrong, no matter how good the clinic is. Dose-escalation decisions run on bioanalytical turnaround: slow assays mean slow cohorts. Select the lab during synopsis development, not after the protocol is final.
What should a sponsor check when selecting a bioanalytical lab?
Six checks. Every one of them is verify-before-you-commit:
GCP/GCLP compliance — not “GLP accreditation.” The lab analyzes clinical samples, so require GCP/GCLP compliance. GLP governs nonclinical studies; a lab with GLP experience for nonclinical support is a plus, but “GLP-accredited” is the wrong standard for a clinical bioanalytical lab.
PK methods validated or transferred per ICH M10. Chromatographic (LC-MS/MS) or ligand-binding methods, as appropriate to the molecule. Method validation or a documented method transfer — not a handshake.
ADA and biomarker assays validated fit-for-purpose. Immunogenicity (ADA) and biomarker assays must be validated under fit-for-purpose approaches consistent with FDA and EMA immunogenicity guidance. Be explicit about this: ICH M10 does NOT cover immunogenicity or biomarker assays. A lab that answers “we follow M10” for an ADA assay has not answered the question.
Documented regulatory inspection history. Ask for inspection history and findings. There is no formal “prior data acceptance” register at INVIMA, ANVISA, or ANMAT — do not let anyone sell you a listing that does not exist. Prefer labs that sit inside a regulator-authorized Phase 1 center (for example, under ANMAT’s post-7516/2025 FIH-center authorization framework).
Turnaround SLA fast enough for dose escalation. Dose-escalation committees decide on data. Get the turnaround commitment in writing, and keep a central-lab fallback (US or EU) for any method not locally validated.
Lock the assay format, matrices, and biomarker panel early. In the synopsis — not during study startup. Late changes to the assay panel are one of the most common preventable causes of FIH delay.
Criterion
What good looks like
Red flag
Compliance standard
GCP/GCLP-compliant lab; GLP experience for nonclinical support a plus
“GLP-accredited” presented as the clinical-lab standard
PK validation
ICH M10-validated or transferred methods (LC-MS/MS or LBA)
No validation package; verbal assurance only
ADA / biomarkers
Fit-for-purpose validation per FDA/EMA immunogenicity guidance
“We follow ICH M10” for an ADA assay
Regulatory track record
Documented inspection history; lab inside a regulator-authorized Phase 1 center
Claims of a formal “accepted lab” register that does not exist
Turnaround
Written SLA supporting dose-escalation cadence; central-lab fallback
No SLA; no fallback plan
Assay lock
Format, matrices, and panel fixed in the synopsis
Assay decisions drifting into startup
Does INVIMA B/BE certification or ISO 17025 settle the question?
No — and this is a common expensive misunderstanding. INVIMA’s bioavailability/bioequivalence (B/BE) certification is a BE-only scheme built for generic-drug registration. For an FIH program, treat it as an optional quality signal about a lab’s general discipline — never as an FIH requirement. A lab without B/BE certification is not disqualified from FIH work, and a lab with it is not automatically qualified.
ISO 17025 works the same way: a genuine differentiator in laboratory competence, but not a requirement for FIH bioanalysis. Use it as a tiebreaker between two otherwise equal labs, not as a gate.
Where do healthy-volunteer Phase 1 units fit in Latin America?
Argentina and Chile make a strong primary/backup healthy-volunteer pairing: established Phase 1 unit infrastructure, experienced investigators, and — in Argentina — a defined Phase I review clock of 35 technical plus 10 administrative business days (about 45 total) under ANMAT Disposición 7516/2025, Annex III. Mexico and Brazil have deep clinical infrastructure, but their healthy-volunteer Phase 1 capacity is less established than Argentina’s and Chile’s — factor that into country selection for a healthy-volunteer study, not just the regulatory clock.
Frequently asked questions
Is GLP accreditation required for the bioanalytical lab?
No. GLP governs nonclinical studies. For a lab analyzing clinical FIH samples, require GCP/GCLP compliance. GLP experience supporting nonclinical work is a bonus, not the standard.
Does ICH M10 cover immunogenicity and biomarker assays?
No. ICH M10 covers chromatographic and ligand-binding PK assays. ADA and biomarker assays need fit-for-purpose validation consistent with FDA and EMA immunogenicity guidance.
Can I use my US or EU central lab instead of a local one?
Yes — keep a central-lab fallback for any method not locally validated. Build it into the plan and the budget from the start, not as an emergency fix.
Does an INVIMA B/BE certificate qualify a lab for FIH bioanalysis?
It is an optional quality signal only. B/BE certification is a generic-registration scheme, not an FIH requirement.
Is there an official list of regulator-accepted bioanalytical labs?
No. There is no formal prior-acceptance register at INVIMA, ANVISA, or ANMAT. Evaluate documented inspection history instead.
How fast can a Phase 1 start in Argentina?
ANMAT’s Phase I clock is 35 technical plus 10 administrative business days — about 45 total — under Disposición 7516/2025, Annex III.
That discipline — lock the assays early, select the lab on documented evidence, and pair your healthy-volunteer units across countries — is what First-in-Human for Biopharma in Latin America: Phase 1, Healthy Volunteers, and Bioanalytical Lab Selection is really about. The lab is part of the study design, not a procurement line item.
References
ICH M10 — Bioanalytical Method Validation and Study Sample Analysis.
FDA and EMA immunogenicity/ADA assay guidance (fit-for-purpose validation).
ANMAT Disposición 7516/2025, Annex III (Phase I review clock: 35 technical + 10 administrative business days).
OECD Principles of GLP and GCLP guidance documents (scope: nonclinical vs. clinical-sample analysis).
The homework every investigator completes — even the preselected one.
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 sponsor once told us our site-search line item seemed very high. Fair question. Here is the answer, with nothing hidden: how we qualify FIH sites and investigators in Latin America, step by step. We have been doing this for twenty years — and the method is the same whether the investigator is new to us or preselected by the sponsor.
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.
Site qualification — the structured process of selecting and vetting a clinical site and investigator before a study starts — distinct from site initiation, which activates an already-selected site.
CRO (contract research organization) — the company contracted to run the clinical trial on the sponsor's behalf.
What does the site-search line item actually include?
Four things: questionnaire build, sponsor approval, outreach, and evaluation. The questionnaire is built for your device and your protocol — not a generic form. You approve it before it goes out. Then we run outreach to candidate sites and evaluate the responses on site. That is the line item. It looks expensive until you price a wrong site: a site that cannot enroll, cannot execute, or cannot survive an inspection costs multiples of the qualification fee.
What are the four steps of qualification?
Step
What happens
Why it matters
1. Questionnaire build
A site-qualification questionnaire tailored to the device, the procedure, and the protocol.
Generic forms miss device-specific risks.
2. Sponsor approval
You review and approve the questionnaire before outreach begins.
No surprises about what we are screening for.
3. Outreach
Structured contact with candidate sites and investigators.
Breadth before depth — the shortlist earns its place.
4. On-site evaluation
In-person assessment of the site and the team.
Paper claims get verified where the work happens.
What do you assess at each site?
Five elements — the whole environment, not just the physician's CV:
The investigator — clinical credibility, FIH-relevant experience, and genuine interest. Interest is a qualification criterion, not a pleasantry — it predicts enrollment.
Patient flow — real, current, eligible-patient volume for this indication — the direct input to the enrollment model.
Coordinators — the study coordinators who run the day-to-day: experience, bandwidth, and language capability.
Equipment — the procedure requires specific equipment; its presence and condition are verified on site, not assumed from a brochure.
Certified site — the site's certifications and inspection readiness, so the data file survives regulatory scrutiny.
What if we already chose our investigator?
Even a preselected investigator gets the homework. The questionnaire goes out, the evaluation happens, and the environment gets qualified. Preselection is a head start, not a waiver — some of our best-performing sites were preselected, and some preselected sites failed the evaluation. The process is the same either way, because how we qualify FIH sites and investigators in Latin America does not change with who made the introduction.
Does the investigator need experience with our exact device?
Exact prior-device experience is nice to have, not required. What is required: relevant procedural skill, research discipline, real patient access, and a team that can execute a first-in-human protocol. A great investigator learns a new device quickly; a weak environment cannot be fixed by device familiarity. We weight the five elements accordingly.
What should I ask any CRO about site qualification?
Show me the questionnaire you would build for my device — is it tailored or generic?
Who approves it, and when — before or after outreach?
What specifically happens during the on-site evaluation?
What are your go/no-go criteria?
What happens when a preselected investigator fails the evaluation?
How do you verify patient flow — self-reported numbers or chart-level evidence?
Frequently asked questions
Have you worked with these sites before?
We have been doing this for twenty years, so the answer is often yes — but every program re-qualifies. Past work is a head start, not a substitute for the current questionnaire and evaluation.
Why not skip qualification for a site we already know?
Because sites change: investigators move, coordinators turn over, equipment ages, patient flow shifts. The homework verifies the site as it is today, not as it was in the last program.
How long does site qualification take?
It runs in parallel with regulatory preparation; the timeline depends on the country, the number of candidate sites, and how quickly the sponsor approves the questionnaire. Ask us to map it against your startup clock.
What is the difference between site qualification and site initiation?
Qualification selects the site — it answers whether this site should run the study. Initiation activates an already-selected site: training, contracts, and green-lighting enrollment.
Do you qualify backup sites?
Yes. Backup sites are prequalified before first patient in, so adding enrollment capacity later is a decision, not a new project.
What fails a site most often?
In our experience, it is rarely the investigator's skill — it is patient flow that does not match the claims, or coordinator bandwidth that cannot absorb a first-in-human protocol's demands.
See the questionnaire we would build for your device
bioaccess® qualifies FIH sites and investigators across Latin America — questionnaire, sponsor approval, outreach, and on-site evaluation, with the whole environment assessed. Send us your protocol and we will show you what the homework looks like.