PRACTICAL GUIDE | 2026

The Two-Country FIH Strategy: De-risking Timelines and Enrollment with Parallel Programs

One country is a plan. Two countries are insurance.

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

FIH is first-in-human: the first time a device or drug is tested in people. A two-country FIH strategy does not mean running the same study twice. It means designing one program with staged, sequential cohorts across two countries in Latin America — early cohorts enrolling in the faster-activating market while the second market completes startup, with each cohort's safety data reviewed before the next begins. The two-country FIH strategy is timeline insurance: if one country's startup stalls or enrollment underperforms, the program still moves.

This is a design framework, not a promise about any specific pair of countries. Every pairing below is illustrative — an example of how the selection logic works, not a guaranteed outcome. The right pair depends on your device, your indication, and the feasibility data.

How does a staged two-country program actually work?

The architecture is sequential cohorts, parallel infrastructure:

1. Country A activates first. Typically a fast-corridor market — Panama, El Salvador, Chile, or Costa Rica — where ethics and regulator submissions run in parallel and activation is measured in weeks. Early cohorts enroll here.
2. Country B starts up in parallel. A larger market — Brazil, Mexico, Colombia, or Argentina — with deeper investigator benches and larger patient populations, on its longer startup clock. Its sites come online as later cohorts begin.
3. Safety gates between cohorts. Each cohort's safety data is reviewed independently before the next cohort enrolls, regardless of which country hosts it. The safety review is per-cohort, not per-country.
4. Enrollment flexes to reality. If Country A enrolls faster than modeled, later cohorts can expand there. If it underperforms, Country B's sites absorb the load. The program is no longer hostage to a single site's patient flow.

Note what this is not: it is not two independent studies, and it is not a way to dodge safety oversight. One protocol, one safety standard, two (or more) national regulatory pathways executed in parallel.

How do you choose the country pair?

Pair selection is the whole game. The framework bioaccess® uses weighs six criteria — and the answer is almost never 'the two fastest countries':

What do illustrative pairings look like?

These are design examples showing how the criteria combine — not recommendations for your study and not guaranteed outcomes:

• Fast corridor + major market. Early cohorts in a fast-activating country (Panama, El Salvador) while a larger market (Brazil, Colombia) completes startup for later cohorts. Speed now, scale and data-rigor perception later.
• Fast corridor + backup. Primary enrollment in one fast country with a second fast country on standby — for example, Panama primary with El Salvador or Chile ready to activate. Lower startup cost than a major-market pairing; less enrollment depth.
• Major market + major market. For programs that need enrollment volume from day one and can fund two full startup tracks. Maximum enrollment insurance, maximum cost.

The pattern: one country buys speed, the other buys depth, redundancy, or perception. If both countries in your pair serve the same purpose, you have not designed a strategy — you have duplicated a budget.

What does the two-country FIH strategy cost — and what does it buy?

Honest accounting. A second country roughly duplicates the startup-phase costs: a second ethics and regulatory filing, a second import-permit workstream, additional site qualification, translation, and CRO startup fees. It does not duplicate the per-patient economics — you are still enrolling the same total cohort; you are buying a second place to enroll them.

What that buys: the two-country FIH strategy converts the two largest FIH schedule risks — a stalled approval and a dry enrollment pipeline — from program-killers into manageable variances. For a venture-backed sponsor whose runway is measured in months, that insurance is frequently cheaper than the delay it prevents. For a well-funded sponsor with a common indication and proven sites, it may be unnecessary. The feasibility data should make the call, not the ambition.

When should you NOT go multi-country?

• The indication enrolls easily and one country's feasibility numbers are strong — redundancy without risk is overhead.
• The budget cannot absorb two startup tracks without cutting corners on monitoring or data quality. Never fund the second country by thinning the first.
• The device or protocol is still changing. Multi-country startup multiplies the cost of every amendment.
• No feasibility work has been done in either country. Two unvalidated countries are not diversification; they are two guesses.

Design checklist: the two-country FIH strategy done right

1. Run feasibility in both countries before committing. Test two to three countries; let site-level patient flow and startup clocks — not enthusiasm — pick the pair.
2. Assign each country a job. Speed, depth, redundancy, perception: if a country has no defined role, cut it.
3. Stage the cohorts with safety gates. Sequential cohorts, independent safety review between them, regardless of which country hosts each cohort.
4. Run both startup tracks in parallel. A backup country that starts up after the primary fails is not a backup; it is a rescue mission.
5. Budget the full second startup. Two filings, two import workstreams, two site qualifications. Price it honestly or do not do it.
6. Keep one protocol and one data standard. ICH-GCP (International Council for Harmonisation Good Clinical Practice) data from qualified sites is what makes multi-country FIH data usable downstream — including for FDA discussions.

Frequently asked questions

Does a two-country FIH study mean double the patients?

No. The total cohort is the same; it is distributed across the two countries' sites. You are buying a second enrollment engine and a second regulatory pathway, not a second study.

Which country should enroll the first cohort?

Usually the faster-activating one, so first-patient-in is not hostage to the slower market's startup clock. The slower market's sites join for later cohorts once activated.

Will the FDA accept FIH data from two Latin American countries?

FDA acceptance turns on ICH-GCP compliance and qualified sites and investigators — not on the number of countries. Multi-country data generated to one protocol and one standard is routinely usable; see our post on FDA acceptance of LATAM FIH data.

How much more does the two-country FIH strategy cost?

Roughly a duplicated startup track: second ethics/regulatory filing, second import workstream, added site qualification and translation. Per-patient costs do not double. The honest comparison is against the cost of a multi-month delay.

Can we add the second country later if the first one stalls?

You can, but a country added in panic starts its clock at zero — months behind. The insurance value comes from running both startup tracks in parallel from the beginning.

Is a two-country strategy the same as a backup site?

No. A backup site is redundancy within one regulatory pathway. A second country is redundancy across regulatory pathways — it protects against approval delays and country-level enrollment failure, which no backup site can fix.

Design the program before you commit to the countries

The two-country FIH strategy is a program-design decision, not a reaction to a stalled startup. bioaccess® builds staged multi-country FIH programs across Latin America — feasibility in two to three markets, parallel startup tracks, sequential cohorts with independent safety review — so your timeline survives contact with reality.

Talk with bioaccess® about your Latin America FIH strategy

Regulatory references

• ICH E6 Good Clinical Practice (GCP) — the data standard underlying multi-country FIH programs.
• bioaccess® blog: Will the FDA Accept Data from a Latin American First-in-Human Trial? (2026).
• bioaccess® blog: How Long Does It Take to Start a First-in-Human Trial in Latin America? A Country-by-Country Startup Clock (2026).
• bioaccess® blog: El Salvador, Panama, Chile, Costa Rica: Inside Latin America's Fast-Track FIH Corridor (2026).
• bioaccess® blog: Patient Recruitment for FIH Trials in Latin America: What the Feasibility Numbers Actually Look Like (2026).

PRACTICAL GUIDE | 2026

No checklist. One standard: convince the committee the product will be safe in humans.

By Julio G. Martinez-Clark

CEO, bioaccess®

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

How much preclinical data do you need before a first-in-human in Latin America? Sponsors usually arrive expecting a checklist — a fixed list of studies, species, and durations that unlocks the clinic. Latin American regulators do not work that way. There is no region-wide preclinical checklist and no codified rule that studies must be GLP-compliant as a condition of first-in-human authorization. There is one standard instead: prove the device or drug will be safe in humans. The burden of proof is on you.

Definitions first. Preclinical (nonclinical) data is the bench and animal testing done before a product enters humans — biocompatibility, toxicology, safety pharmacology, animal performance studies. GLP means good laboratory practice (21 CFR Part 58 in the US): the quality system for nonclinical lab studies. Non-GLP or “R&D-grade” data was generated without that formal quality system. The distinction matters less in Latin America than sponsors expect — and more, later, at FDA.

Is there a fixed preclinical checklist for a LATAM first-in-human?

No. No Latin American regulator publishes a 21 CFR Part 58-style list of required preclinical studies for first-in-human authorization. Colombia’s INVIMA publishes an inventory of approved and not-approved device studies — protocol, product, sponsor, site, investigator — but no required species, sample sizes, durations, or GLP stamp. Chile’s guidance requires preclinical testing and risk evaluation to be exhaustive and sufficient to support the investigation, under ISO 14971, while expressly disclaiming any device-specific test menu. The file that is actually read is a risk-management file plus an investigator’s brochure — not a checklist with boxes to tick.

Is non-GLP preclinical data enough?

For medical devices, yes — with rationale. “If you have the rationale to support why that drug doesn’t need that specific test, that should be sufficient.” R&D-grade data has supported real first-in-human device programs in the region: biocompatibility files, animal performance studies, and risk assessments accepted on the strength of their science rather than their quality-system stamp. A rationale can substitute for a specific test when it explains why the test is unnecessary — not merely that it was skipped.

For drugs and biologics, narrow the claim. Colombia’s medicines framework expects an ICH M3(R2)-type nonclinical safety package, and a non-GLP pivotal toxicology study for a new chemical entity or biologic will draw questions from INVIMA and the ethics committee in the same way it would from FDA. There is no Colombian rule that says “tox studies must be GLP” — but say “no explicit GLP mandate” rather than “non-GLP is accepted.” And note Brazil: ANVISA’s nonclinical guidance expects GLP-conducted safety studies for medicines — the closest thing to an explicit GLP expectation in the region, though it sits at guidance level and applies to drugs, not the device pathway.

Can we reuse the data we already generated abroad?

Yes — origin is not the criterion. Sponsors ask, “Can we just use everything we already used?” — testing done in China, non-GLP work from years ago. The answer: “They don’t care… GLP, non-GLP… regardless of where.” No LATAM regulator imposes a country-of-origin restriction on preclinical data, and in Panama, Art. 102 of Decreto Ejecutivo 21 calls for GLP for preclinical studies performed in Panama; MINSA’s URIS office confirmed in October 2026 that studies done abroad need not be repeated locally, but must be in the investigator’s brochure, follow recognized standards, and are assessed by the ethics committee. Three practical caveats make reuse succeed or fail:

• Language: reports must be submitted in Spanish, or with translation. Budget for it.
• Completeness: for novel products, reviewers expect full study reports — not summaries or slide decks.
• Traceability: show the standard used, the laboratory’s quality system (reviewers frequently ask about accreditation, such as ISO/IEC 17025 or a national GLP program, even where GLP is not mandated), and that the tested article matches the clinical product.

What does a convincing preclinical package look like?

Think of the package as an argument, not an inventory. Every study should answer a human-safety question, and the investigator’s brochure should tie the answers together:

• Map each test to a risk: what human harm does this study rule out, and for which patient population?
• Write the rationale for every test you did not run — the missing study with the best explanation beats the missing study with none.
• In Colombia, include the procedure risk matrix: regulators there want the risk analysis of the clinical procedure, not just the product. Confirm exactly what the committee expects before filing.
• Tie it to ISO 14971 risk management for devices: hazards, harms, controls, and residual risk, all traceable.
• Keep the test article consistent: the device or formulation tested preclinically must be the one going into humans, or the bridge must be explicit.

Does a LATAM-sufficient package satisfy the FDA later?

Not automatically — and this is the strategic point. FDA generally expects IND-enabling safety pharmacology and toxicology to follow GLP (21 CFR Part 58). A package that clears a Latin American first-in-human and a package that supports a US IND are not always the same thing. Design the preclinical program for both endpoints from the start: run the LATAM FIH on the rationale the region accepts, but build the tox package so it also serves the later FDA path. The cheapest preclinical program is the one you run once.

Frequently asked questions

Q: Is GLP required for a first-in-human trial in Colombia?

A: No codified GLP requirement exists for FIH authorization in Colombia — for devices, R&D-grade data with strong rationale has been accepted. For drugs and biologics, expect INVIMA and the ethics committee to probe non-GLP pivotal toxicology closely.

Q: Can we use preclinical data generated in China?

A: Yes. No LATAM regulator restricts preclinical data by country of origin. Submit full study reports in Spanish (or translated), with lab accreditation and test-article traceability documented.

Q: What if we skipped a standard preclinical test?

A: Provide the scientific rationale for why that test was unnecessary for your product. A reasoned omission is defensible; an unexplained gap is not.

Q: Who decides whether our preclinical package is sufficient?

A: The national regulator (e.g., INVIMA in Colombia) together with the ethics committee — which in Colombia does primary review. Their standard is sufficiency of evidence for human safety, not checklist compliance.

Q: How much preclinical data do you need before a first-in-human in Latin America — really?

A: Enough to convince a regulator and an ethics committee that the product will be safe in humans, documented so each study maps to a risk. That is the entire rule. Everything else is execution.

Q: Does non-GLP preclinical data hurt us with FDA later?

A: It can, for drugs: FDA generally expects IND-enabling safety studies under GLP. Plan the program so the LATAM FIH package and the future IND package are built together, not twice.

How much preclinical data do you need before a first-in-human in Latin America? As much as it takes to meet the burden of proof — no more, no less, and no checklist will tell you the number. Bring the rationale, not just the reports.

Talk with bioaccess® about your Latin America FIH strategy

Bring us your existing preclinical package — GLP, non-GLP, generated anywhere. We will assess it against the burden-of-proof standard for your target countries and tell you what is sufficient, what needs a rationale, and what needs to be run.

Talk with bioaccess® about your Latin America FIH strategy

References

• Colombia: Decreto 4725 de 2005 (medical-device regime, including investigational use of unregistered devices); Resolución 8430 de 1993 (ethical norms for health research); INVIMA device clinical-investigation guidance. Resolución 2378 de 2008 adopts GCP for medicines trials.
• Chile: ANDIM/ISP guidance — preclinical testing and risk evaluation must be exhaustive and sufficient under ISO 14971; no device-specific test menu.
• Brazil (medicines): ANVISA nonclinical guide expects GLP-conducted safety studies — guidance-level expectation; confirm current text before relying on it.
• US reference: 21 CFR Part 58 (GLP for nonclinical laboratory studies); ICH M3(R2) (nonclinical safety studies for human trials).
• bioaccess® preclinical sufficiency experience across LATAM FIH programs, 2021–2026. Last verified: September 2026.

PRACTICAL GUIDE | 2026

When the rebate math works, when it doesn’t, and what sponsors learn too late.

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.

Latin America vs. Australia for first-in-human trials is the comparison sponsors actually run. Australia is bioaccess®’s real FIH competitor — sponsors arrive already sold on offshore FIH and ask us to argue the other side. So here is the honest version: Australia’s genuine advantages, where it falls short, where Latin America wins, and when each region is the right call.

Definitions first. FIH means first-in-human — the first testing of a device or drug in people. Australia’s R&D Tax Incentive (RDTI) is a government tax offset for eligible research and development: a 43.5% refundable offset for companies with aggregated turnover under A$20 million, meaning the credit is paid in cash even to companies with no tax liability. TGA is Australia’s Therapeutic Goods Administration, the national regulator.

What does Australia offer FIH sponsors?

Australia’s headline advantage is real money. The RDTI provides a 43.5% refundable tax offset on eligible R&D expenditure for companies with aggregated turnover below A$20 million (larger companies receive a non-refundable offset starting at 38.5%, scaling with R&D intensity). For a cash-constrained startup, a cash refund on nearly half of eligible spend is a powerful funding mechanism. Clinical trials are a core use case: biotech companies routinely claim trial costs, and the program is jointly administered by AusIndustry and the Australian Taxation Office.

Beyond the rebate: English-language operations, mature TGA-regulated early-phase units, world-class hospitals in Sydney and Melbourne, and a global reputation for high-quality data that regulators everywhere recognize. Foreign companies can access the incentive, typically through an Australian subsidiary or local structure, provided the R&D is conducted in Australia — though eligibility turns on who incurs the expenditure and who owns the resulting IP, a frequent focus of audits.

Where does Australia fall short?

Cost before the rebate is high — early-phase unit fees, investigator costs, and operational overhead run well above Latin American levels, which is why the incentive exists at all. Recruitment is the deeper problem: Australia’s population is small and trial competition for patients is intense, so enrollment can drag. And approvals are not the smooth path sponsors expect — one US sponsor told us it lost three years in Australia because it could not get approval. That is one company’s experience, not a national statistic, but it is the kind of story that makes sponsors ask us for the comparison in the first place.

Where does Latin America win?

• Cost: typically 30–50%+ savings versus the US — lower per-patient and operational costs, with no rebate paperwork required to realize them.
• Speed: activation in as little as four weeks in the fast corridor (Panama, Chile, El Salvador, Costa Rica) versus the eight-month timelines sponsors report elsewhere.
• Recruitment: deep investigator access and large treatment-naïve populations; enrollment risk — the binding constraint in most FIH programs — is structurally lower.
• Time zones: US-aligned working hours, versus a 10–16 hour gap with Australia.
• Data acceptance: ICH-GCP data from qualified LATAM sites is routinely usable with FDA under 21 CFR 812.28 (devices) and 21 CFR 312.120 (drugs).

When should you choose Australia over Latin America?

Honestly: when the rebate math genuinely works for you. If you already have — or will build — an Australian entity conducting eligible R&D, the 43.5% cash offset can beat LATAM’s base-cost advantage on paper. Australia also fits sponsors who specifically value TGA oversight, whose therapeutic area matches an Australian unit’s deep expertise, or whose investors simply prefer the jurisdiction. Run both models with real quotes before deciding — rebate-on-paper versus all-in cost are different numbers.

When should you choose Latin America?

When speed is the critical path. When recruitment risk — not budget — is what keeps you up at night. When you are a startup that needs the lowest absolute cash outlay, not a future tax refund. And when you want physician-level local execution in your time zone, with FDA-usable GCP data at the end of it.

Frequently asked questions

Q: Can a US company claim Australia’s R&D tax incentive for a clinical trial?

A: Yes, if the R&D is conducted in Australia — typically through an Australian subsidiary or local arrangement. Eligibility depends on who incurs the expenditure and effective ownership of the resulting IP, which auditors scrutinize.

Q: Is Australia cheaper than Latin America after the 43.5% rebate?

A: Sometimes on paper. The rebate applies to eligible expenditure; Australia’s pre-rebate costs are substantially higher, and the refund arrives after filing. Compare all-in, time-adjusted cost with real quotes — not headline rates.

Q: Will FDA accept FIH data from both Australia and Latin America?

A: Yes, under the same rules: GCP-compliant data from qualified sites. Geography is not the criterion in either case.

Q: Can we run FIH in both regions?

A: Yes — staged or parallel multi-region programs are common for de-risking timelines and enrollment. Each region’s data must meet the same GCP standard.

Q: How long do approvals take in Australia?

A: Timelines vary by study and pathway; sponsors have reported significant delays, including multi-year cases. Verify current expectations with a local regulatory advisor for your specific program.

Q: Latin America vs. Australia for first-in-human trials — what is the simplest decision rule?

A: If your binding constraint is absolute cash and speed to data, Latin America usually wins. If you have an Australian structure and the rebate math closes the gap, Australia deserves a real quote. Never decide on reputation alone — decide on quotes, clocks, and enrollment risk.

Latin America vs. Australia for first-in-human trials is not a contest with one winner. It is a trade: a world-class rebate compensating for world-class costs and recruitment friction, against lower base costs, faster activation, and deeper enrollment access. Know which constraint binds your program — and choose accordingly.

Talk with bioaccess® about your Latin America FIH strategy

Considering Australia, Latin America, or both? Send us your synopsis and we will model the two paths side by side — real startup clocks, real enrollment assumptions, real budget anatomy — so you decide on numbers, not narratives.

Talk with bioaccess® about your Latin America FIH strategy

References

• WilmerHale Launch (April 2026): Australia’s R&D Tax Incentive — 43.5% refundable offset for eligible entities with aggregated turnover below A$20 million — https://launch.wilmerhale.com/research/blog/20260413-dont-let-australias-r-d-tax-incentive-trigger-unintended-us-international-tax-cost-sharing-issues
• Opportuna Legal: Australia’s R&D Tax Incentive — general overview for clinical trials — https://www.opportunalegal.com.au/single-post/australia-s-r-d-tax-incentive-a-general-overview-for-clinical-trials
• bioaccess® client experience with Australia benchmarking and LATAM FIH programs, 2021–2026. Last verified: September 2026.

PRACTICAL GUIDE | 2026

El Salvador, Panama, Chile, Costa Rica: Inside Latin America's Fast-Track FIH Corridor

Speed is a pathway design, not a shortcut.

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

FIH is first-in-human: the first time a device or drug is tested in people. Sponsors ask which Latin American country activates fastest, and the honest answer has been stable for years: Panama, El Salvador, Chile, and Costa Rica. This is the fast-track FIH corridor — not because standards are lower, but because the pathway is designed for speed: ethics committee and regulator receive submissions in parallel rather than sequentially, committee cadence is frequent, and requirements are predictable.

A companion post — How Long Does It Take to Start a First-in-Human Trial in Latin America? A Country-by-Country Startup Clock — publishes the comparison table across all major markets. This post is the deep dive: why each corridor country is fast, what infrastructure each offers, where each falls short, and which study types fit. Timelines below are drawn from bioaccess® operational experience; treat country-level clocks as indicative and confirm the current pathway before planning around them.

Why is Panama the corridor's proven sprinter?

Panama is the country bioaccess® cites when sponsors ask whether fast activation is real: 'We got it activated in about 15 days in Panama.' The mechanics behind that number: the ethics submission receives an ID number in about three business days, the Ministry of Health (MINSA) pathway runs in parallel with the ethics review, and requirements are few — 'we barely get any requirements.'

• Speed drivers: parallel ethics/regulator submissions; ~3-business-day ethics ID; predictable, light requirements.
• Infrastructure: experienced private-hospital research sites; established trial import mechanics.
• Where it falls short: small population — recruitment can be the constraint, not the approval. Panama rewards narrow, well-defined indications and punishes optimistic enrollment models.
• Cost tier: mid-to-upper among corridor countries; hospital fees run higher than El Salvador's.
• Best fit: small early cohorts where speed to first-patient-in dominates and the indication matches available patient flow.

What makes El Salvador the cost leader?

El Salvador matches the corridor on pathway speed and undercuts it on cost. Julio's standing comparison: 'hospital fees in El Salvador are way less than in Panama.' For budget-sensitive FIH programs, that gap can decide the country.

• Speed drivers: fast ethics and regulatory pathway; parallel submissions where applicable.
• Infrastructure: capable hospital sites at a lower cost tier; growing investigator experience with early-stage trials.
• Where it falls short: small population and a thinner investigator bench than Panama or Chile — backup sites matter more here.
• Cost tier: the corridor's cost leader on hospital and site fees.
• Best fit: cost-sensitive FIH programs with modest enrollment targets and a defined patient population.

Why does Chile punch above its weight?

Chile is the corridor country that also sits in the top tier of perceived data rigor — alongside Brazil, Argentina, Mexico, and Colombia in how regulators and partners view its clinical data. That combination is rare: corridor speed without the 'small fast market' discount some sponsors worry about.

• Speed drivers: efficient ethics and Instituto de Salud Pública (ISP) pathways; experienced committees.
• Infrastructure: deep investigator bench, strong academic hospitals, mature research ecosystem.
• Where it falls short: higher cost tier than El Salvador or Panama; competition for top investigators and sites.
• Cost tier: upper among corridor countries — you pay for depth and perception.
• Best fit: programs where the FIH data must impress FDA reviewers or licensing partners, and where enrollment needs a real investigator bench.

What does Costa Rica offer?

Costa Rica completes the corridor: a fast, stable pathway with solid hospital infrastructure and a research-friendly regulatory posture. It is the corridor's quiet option — less cited in sponsor conversations than Panama, but consistent in execution.

• Speed drivers: streamlined ethics and Ministry of Health pathway; predictable requirements.
• Infrastructure: strong private-hospital sector; experienced coordinators.
• Where it falls short: small population like the rest of the corridor; investigator depth concentrated in a few centers.
• Cost tier: mid-range within the corridor.
• Best fit: sponsors who want corridor speed with institutional stability and are comfortable with concentrated site options.

How do the four corridor countries compare?

Clocks are indicative and drawn from bioaccess® operational experience — confirm the current pathway per country before building a program around any specific number.

Which study types fit the fast-track FIH corridor — and which do not?

• Strong fit: small first-in-human cohorts (the classic 5–15 patient early study); early feasibility studies; programs where months of runway are worth more than marginal per-patient savings.
• Conditional fit: moderate-enrollment studies, if feasibility confirms real patient flow at the specific sites — investigator interest beats headline population.
• Poor fit: large-enrollment programs that need deep patient pools; indications with no established referral flow in small markets. That is when the major markets (Brazil, Mexico, Colombia, Argentina) earn their longer clocks.

The recurring mistake: picking the fastest country, then discovering the indication cannot enroll there. Speed to activation means nothing if enrollment never starts. Inside Latin America's fast-track FIH corridor, feasibility — real site-level patient flow for your indication — is the selection step that matters more than the startup clock.

Frequently asked questions

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

Panama, El Salvador, Chile, and Costa Rica form the fast-track FIH corridor, with activation measured in weeks versus 6–9 months in the major markets. Panama holds the demonstrated record at bioaccess: about 15 days to activation.

Why is Panama so fast for clinical trial startup?

Ethics committee and regulator (MINSA) submissions run in parallel; the ethics submission receives an ID in about three business days; and requirements are light — 'we barely get any requirements.' It is pathway design, not lower standards.

Is El Salvador really cheaper than Panama for FIH trials?

On hospital and site fees, yes — materially so, in bioaccess® experience. El Salvador is the corridor's cost leader, which makes it the value option for budget-sensitive programs with modest enrollment needs.

Does fast mean lower data quality for FDA purposes?

No. FDA acceptance turns on ICH-GCP (International Council for Harmonisation Good Clinical Practice) compliance and qualified sites and investigators, not on how fast the trial activated. Chile additionally offers top-tier perceived data rigor for sponsors who need it.

What is the biggest risk of choosing a fast-corridor country?

Enrollment. All four are small markets; the approval is rarely the constraint — patient flow is. Model enrollment from actual site flow, not population, and prequalify backup sites.

Should we run feasibility in more than one corridor country?

Yes. Test two to three countries and let the feasibility numbers choose. That screening costs little and is the cheapest insurance in the program.

Find your corridor fit before you commit to a clock

Inside Latin America's fast-track FIH corridor, the right country is the one whose patient flow matches your indication — not simply the fastest one. bioaccess® runs feasibility across two to three corridor markets, models enrollment from real site flow, and activates in weeks where the data supports it.

Talk with bioaccess® about your Latin America FIH strategy

Regulatory references

• Panama: Ministry of Health (MINSA) clinical trial and ethics submission procedures; timelines per bioaccess® operational experience, confirm current procedure at filing.
• El Salvador: national clinical trial authorization procedures; cost comparisons per bioaccess® operational experience.
• Chile: Instituto de Salud Pública (ISP) clinical trial procedures; confirm current procedure at filing.
• Costa Rica: Ministry of Health clinical trial procedures; confirm current procedure at filing.
• ICH E6 Good Clinical Practice (GCP).
• bioaccess® blog: How Long Does It Take to Start a First-in-Human Trial in Latin America? A Country-by-Country Startup Clock (2026).
• bioaccess® blog: Will the FDA Accept Data from a Latin American First-in-Human Trial? (2026).

PRACTICAL GUIDE | 2026

The parallel pathway most sponsors don't expect.

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 expect a sequence: ethics committee first, regulator second. In Latin America's fast markets, that is not how it works. The ethics committee and the regulator receive submissions in parallel — a designed-in timeline accelerator that most sponsors never see coming. Here is how ethics committees in Latin America actually shape the startup clock, and why the sponsors who plan for parallelism start faster.

• 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.
• Ethics committee — the independent body that reviews a trial's ethics — known as an IRB (institutional review board) in the United States.
• Regulator — the national health authority that authorizes the clinical trial — for example, INVIMA in Colombia or COFEPRIS in Mexico.
• Fast corridor — bioaccess®'s term for the fastest FIH startup markets in the region: Panama, Chile, El Salvador, and Costa Rica — where ethics and regulatory approval of a complete submission typically took about 1 to 3 months in our recent plans.
• Committee cadence — how often an ethics committee meets and issues decisions — a direct input to the startup clock.

Do the ethics committee and the regulator review in parallel or sequentially?

In the fast markets, in parallel. The ethics committee and the national regulator receive the submission at the same time and run their reviews concurrently. This is not a shortcut or a favor — it is the designed pathway. Sponsors who plan for a sequential process over-budget their startup clock by weeks they do not need to spend.

Why does parallel submission change the timeline?

Sequential review adds the two clocks together. Parallel review runs them against each other — the startup clock becomes the longer of the two reviews, not the sum. In a fast market, that design choice is a meaningful part of how activation lands in weeks rather than months. It is also why the submission package has to be complete on day one: parallelism only works if neither reviewer is waiting on documents.

Which markets does this apply to?

The fast corridor: Panama, Chile, El Salvador, and Costa Rica. These are the markets where the parallel pathway is an established part of startup design. Outside the corridor, confirm the pathway market by market — do not assume parallelism travels. Pathway design starts with knowing which map you are on.

What does committee cadence have to do with the startup clock?

Committees meet on schedules, and those schedules are a line item in the startup clock — alongside translation, import permits, and contracting. Committee cadence, meeting frequency, and the national-versus-hospital pathway all shape how fast a parallel submission converts into an approval. We plan around the actual cadence of the actual committee reviewing the study — not a generic average, and not a number from a brochure.

How fast can activation actually be?

In Panama, we have seen activation in about 15 days. The ethics-submission ID number arrives in about three business days, and the regulator's follow-up requirements are typically minimal — in our experience, we barely get any requirements. Those are real outcomes from real programs, not a promised standard: the parallel pathway makes them possible, and execution makes them happen.

Designing the ethics pathway: a checklist

• Confirm whether the target market runs ethics and regulatory review in parallel or sequentially — before quoting the startup clock.
• Get both packages submission-ready at once; parallelism fails if either reviewer waits on documents.
• Confirm the actual committee's cadence during startup planning and build the clock from it.
• Resolve the national-versus-hospital pathway question where both exist.
• Use the universal submission package (protocol, IB, ICF, CRF, insurance, preclinical) to prevent rounds of committee questions — the most common preventable delay.
• Never select a committee for leniency; select the pathway for design.

Frequently asked questions

Should we submit to the ethics committee before the regulator?

In the fast-corridor markets, submit to both at once — that is the designed pathway. Planning for a sequential process over-budgets the startup clock.

Does parallel submission mean a less rigorous ethics review?

No. It is the same review, run concurrently. Parallelism changes timing, not standards.

Which is better: a hospital or a national ethics committee?

It depends on the market and the program. That is a pathway-design question, not a shopping question — confirm which pathways exist in the target market first.

How do we plan around committee meeting schedules?

Confirm the actual committee's cadence during startup planning and build the clock from it. This post states no per-country cadence as fact — cadence is verified program by program.

Is parallel submission available in Brazil or Mexico?

Confirm market by market. This post describes the fast corridor — Panama, Chile, El Salvador, and Costa Rica — where the parallel pathway is established.

What is the biggest preventable delay in ethics review?

An incomplete submission package cycling through rounds of committee questions. The universal six-document package is the prevention.

Design the pathway before you file

bioaccess® designs FIH startup pathways across Latin America — parallel submissions where the market supports them, committee cadence built into the clock, and a submission package that survives first review. Tell us your target markets; we will map the fastest honest route.

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

References

• Parallel-submission practice described reflects bioaccess® programs in the fast-corridor markets (Panama, Chile, El Salvador, Costa Rica) and sponsor Q&A, 2021–2026 (all clients anonymized).
• Panama program outcomes cited (about 15-day activation; about three business days for the ethics-submission ID) are real program results, not guaranteed standards.
• No dedicated ethics-committee post previously existed on the bioaccess® blog.
• General: confirm the submission pathway and committee cadence for the specific market and committee before committing timelines.

By Julio G. Martinez-Clark

CEO, bioaccess®

General information, not legal, customs or regulatory advice. Official clocks are cited to the regulation or the agency’s own page; each country row links the source. Durations marked “bioaccess® experience” come from our recent study timelines and import trackers. They are planning estimates, not legal deadlines or guaranteed turnarounds. Fees, duties and broker charges are not listed where we could not find an official figure; those cells say “confirm with us”. Sources last checked: 29 October 2026.

In this guide: The short answer · How import works everywhere · Timeline · Country table · Our observed lead times · The US export step · Importer of record · Documents · Fees and costs · What slows import · Checklist · Glossary · FAQ

The short answer

In the Latin American countries in this guide, an investigational drug or device enters under a research import authorization tied to the trial, not under a commercial import. The product and quantities must match the approved protocol. Three roles need a name in each country: the applicant who files the permit, the importer of record who is responsible at customs, and the customs broker. Sometimes one company does all three; the rules differ by country.

Official permit clocks are short once the file is complete. They range from about 48 hours in Argentina and 3 business days in Peru to 15 business days in Panama and 30 business days in Brazil (drug trials). The real lead time is longer: the US export step, the shipment, customs release and, in some countries, an inspection come on top. bioaccess® experience: in Panama, one device shipment reached the sites about 2 weeks after the permit request. In El Salvador, laboratory kits took 38 days from the inventory declaration to the site, and our device plan allows about 69 working days (roughly 3 months) for the permit, shipment and device inspection together.

The fix is sequencing. Name the applicant, importer of record and broker when you choose the country, prepare the import file during the submission, and file the moment the country allows it. In Brazil (drug trials) the import document can be issued before approval, and in Argentina the request can be filed before the final approval. Filing early does not authorize use before approval.

How trial import works in every country

The mechanics differ, but the logic is the same in drug and device trials:

1. The trial is authorized first (or, in Brazil and Argentina, the import is filed alongside the trial application). The import authorization refers to the trial.
2. The applicant files a research import request with the health authority: typically a product list, quantities, lots, an invoice or proforma, labels and the approval reference. Each country’s list differs (see the table).
3. The authority issues a permit (or a “visto bueno”, certificate or import document), often through the country’s single foreign-trade window (VUCE in several countries).
4. The product ships with the permit, clears customs as a research import, and is received and stored under the protocol’s conditions.
5. Some countries add a step after arrival: Chile needs a “use and disposal” authorization once the product reaches the authorized warehouse, and El Salvador may inspect devices.

Quantities, names and lots must match the approved protocol and the permit. In our recent trackers, document rounds, not the authority’s clock, drove the delays (bioaccess® experience).

Where import sits in the startup timeline

Country by country: permits, importer and official clocks

Each row links the official source. The “who” column shows who the source says files, signs or is named on the paperwork. That is not always the same as the customs importer of record; where the source does not say, the row says “confirm with us”. Colombia note: bioaccess® runs first-in-human studies in Colombia now.

Notes on the table.

• Peru: on 29 October 2026 the official page said the service has been disabled since 20 August 2026, that its information is being updated, and asked applicants to confirm fees and requirements by phone at (01) 631 4300. Confirm before you plan.
• Devices: most rows are written for drugs and trial supplies. Device coverage is explicit in Mexico (COFEPRIS-01-015) and in Colombia’s FM052 list, which includes devices and reagents. Brazil runs device trials under RDC 837/2023; confirm the import document for a device study with us. For the other countries, confirm the device route with us.
• Canada, for comparison: the Health Canada No Objection Letter travels with the drug shipment; importers are authorized by the sponsor and listed in Appendix 1 of the application form, and investigators may act as importers (CTA guidance, 2.7.5). For devices, the Letter of Authorization is the legal authorization to import the authorized number of devices (ITA guidance, 2.3.6).

What we have seen in practice

These are real durations from our recent study trackers and plans (bioaccess® experience). They include the steps the official clocks leave out.

Two lessons from these trackers. First, in El Salvador the round of observations took about two weeks from the observations to the permit; the authority’s clock itself was short. Second, the authority’s holidays and closures count. Build them into the plan.

The step sponsors forget: leaving the United States

If your product ships from the United States, the US export step depends on the product.

Who can be the importer of record

The importer of record is the legal person responsible for the import declaration and the import obligations. For a trial, that is a regulatory role, not a freight task.

• Some countries say who files or signs. Argentina requires an ANMAT-enabled firm, with the form signed by its technical director. Costa Rica allows drug imports only through registered droguerías. Peru names the sponsor or the authorized investigator as applicant. In the Dominican Republic the invoice must be in the principal or national investigator’s name; who acts as importer of record there: confirm with us.
• Some countries let the sponsor or its CRO file. Colombia and Ecuador name the sponsor or the CRO as applicant.
• Filing is not always the same as importing. The applicant on the permit, the person who signs, the name on the invoice and the customs importer of record can be different. Confirm all four for each country.
• The importer of record is not the registration holder. A commercial registration holder sells approved products. A trial importer brings in unapproved product for the protocol only. They can be the same company, but the processes are different. See importer of record vs registration holder.

In bioaccess® practice we confirm the importer of record for each country at the start, put that name on the permit, the insurance and the site’s receiving procedure, and use a broker who has cleared research imports before. More detail: importer of record for multi-country trials.

Documents to prepare before the first shipment

For device accountability through the study, see investigational device accountability in a first-in-human study.

Fees, duties and broker costs

We do not publish broker or duty estimates because they change with the product classification and the shipment plan. We quote them per study.

What slows import and how to prevent it

Import readiness checklist

• ☐ Importer of record named for each country, with a signed agreement
• ☐ Customs broker experienced with research imports engaged
• ☐ Product list (codes, quantities, lots or serials, expiry) matches the protocol
• ☐ Invoice or proforma meets the country’s data requirements
• ☐ Labels approved, in Spanish where required
• ☐ Certificates (analysis, GMP, stability) ready for drug shipments
• ☐ Trial approval references ready, or pre-approval filing used where allowed
• ☐ US export approval or drug export certification done
• ☐ Temperature range, packaging and site receiving procedure agreed
• ☐ Post-arrival step booked (Chile authorization, device inspection)
• ☐ Resupply and return or destruction plan agreed

Glossary

• Importer of record (IOR): the legal person responsible for the import declaration and import obligations in the country.
• Customs broker: the licensed agent who files the customs declaration for the importer.
• VUCE: single foreign-trade window; the online system several countries use to issue permits.
• Visto bueno: an approval stamp from the health authority on an import licence.
• Desalmacenaje: release of goods from customs storage (Costa Rica).
• CDA (Certificado de Destinación Aduanera): Chile’s customs destination certificate from ISP.
• DDCM / DEEC: Brazil’s drug development dossier and the trial-specific dossier filed under it.
• Proforma: a preliminary invoice used to request permits before the final invoice exists.
• 801(e)(2) export request: FDA approval needed to export an unapproved investigational device to any Latin American country (none is on FDA’s tier-one list).
• Tier-one country: FDA’s short list of countries with simplified export routes.

Frequently asked questions

Do I need the trial approved before I can import?
Usually yes; the permit refers to the approval. For drug trials in Brazil, ANVISA can issue the import document within 30 business days of the trial filing, before approval, but the product cannot be distributed until the approval is published. Argentina accepts proof that the trial file was opened instead of the final approval.

Who should be the importer of record?
It depends on the country. Argentina requires an ANMAT-enabled firm; for drugs, Costa Rica requires a registered droguería; Peru names the sponsor or the authorized investigator as applicant; Colombia and Ecuador allow the sponsor or the CRO to file. Confirm the applicant and the customs importer of record per country before you submit.

How long does import take?
Official permit clocks run from about 48 hours (Argentina) to 30 business days (Brazil, drug trials). In our experience, one Panama device shipment reached the sites about 2 weeks after the permit request; El Salvador laboratory kits took 38 days from inventory declaration to site; and our El Salvador device plan allows about 69 working days for permit, shipment and inspection.

Is the import process different for drugs and devices?
The logic is the same. Some countries have separate permits for devices, such as Mexico’s COFEPRIS-01-015, and El Salvador may inspect devices. The US export step is also different for devices and drugs.

Do I need FDA permission to ship an investigational device to Latin America?
Yes, for Latin America. Exporting an unapproved device for investigational use to a country that is not on FDA’s tier-one list needs FDA approval under section 801(e)(2), with a letter from the importing country’s government. Canada is on the tier-one list, so export there needs no FDA authorization if the country’s laws are followed.

Do I need FDA permission to ship an investigational drug?
Not always. You can export under an IND in effect, or, if you meet its conditions, send FDA a certification when the drug is first exported and keep compliance records.

Can someone hand-carry product to the site?
Don’t plan on it. Import in these countries is tied to a research authorization, and a unit that enters outside it has no import record for accountability. Confirm with us before any exception.

Are customs duties waived for trial products?
It depends on the country and the product classification. We confirm duties and broker costs per study.

Can I import more than the protocol needs?
Only what the permit covers. Quantities must match the approved protocol and the permit. Justify spares in the first request and plan resupply as a new request where the country requires it (in Colombia, a new FM052 plus fee).

What happens to unused product at the end?
It needs a documented route: return, destruction or another route the country allows. Peru asks for a sworn no-re-export statement, so confirm the route per country. Plan the exit when you plan the entry.

Plan your import with us

bioaccess® runs the import workstream as part of study startup across the Americas: importer-of-record setup, permits tied to the approval, product lists, US export paperwork and resupply. Contact bioaccess®.

Related reading: Site activation timeline in Latin America · Importer of record for multi-country trials · Importer of record vs registration holder · Device accountability in a first-in-human study · Where to run a first-in-human study · Clinical trial budget by country, line by line

Sources

• Argentina: ANMAT, clinical-research import procedure (12 puntos)
• Brazil: ANVISA RDC 945/2024; ANVISA import codes for research
• Canada: Health Canada CTA guidance; ITA guidance
• Chile: ISP Res. Exenta 5161; ISP CDA procedure
• Colombia: INVIMA ASS-RSA-GU036
• Costa Rica: Decree 44033-S amending the biomedical research regulation
• Dominican Republic: WTO import-licensing notification G/LIC/N/3/DOM/11
• Ecuador: ARCSA import of investigational products
• El Salvador: SRS inventory declaration form
• Guatemala: MSPAS import requirements F-IP-r-01
• Mexico: COFEPRIS response times (COEPRIS BCS list, 2025)
• Panama: Executive Decree 21 of 2026
• Peru: DIGEMID import authorization
• Uruguay: MSP IN-13221-043
• United States: FDA, import and export of investigational devices; 21 CFR 312.110; 21 CFR 812.18

PRACTICAL GUIDE | 2026

What Your CRO Needs to Quote Your First-in-Human Study: The Sponsor's Pre-Quote Checklist

A precise quote is built, not guessed.

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

'Just give me a ballpark.' Every CRO hears it. Here is the honest answer bioaccess® gives: a rough quote from the synopsis alone is fine — precision needs the full package. What your CRO needs to quote your first-in-human study is not a secret; it is three inputs, each unlocking a different level of accuracy.

This post is written to be sent to every prospect who asks for a fast quote. If you are that prospect, work through the checklist below and both sides will save weeks.

What are the three inputs — and what does each one unlock?

Why is the schedule of events the input that matters most?

Because everything billable hangs off it. The schedule of events answers the questions a synopsis never does:

• How many site visits per patient — which sets site payments and monitoring visit counts.
• Which procedures happen where — which sets hospital fees, lab costs, and imaging pass-throughs.
• How long follow-up runs — which sets the CRO's management duration and data-management scope.
• What the staff must do at each visit — which sets coordinator and investigator effort.

Two synopses can describe similar-looking studies with radically different schedules of events — and radically different budgets. Quoting from the synopsis alone means guessing all of the above. An honest CRO will tell you it is guessing; a dishonest one will present the guess as a quote.

What does the feasibility questionnaire cover?

The customized feasibility questionnaire converts the protocol into operational facts. Expect questions on:

• Patient type. Indication, severity, inclusion/exclusion profile — who exactly must be found, and how hard they are to find.
• Activities. What the sites and the CRO must actually do: procedures, assessments, device handling, training, proctoring.
• Visit structure. Number, spacing, duration, and location of visits — site, hospital, or remote.
• Patient count. Target enrollment and any cohort or staging structure.
• Timelines and constraints. When you need first-patient-in, and what cannot move.

Answering this questionnaire is also the fastest way to qualify yourself as a serious prospect. Sponsors who answer it get precise quotes. Sponsors who will not answer it get ranges — and should be suspicious of any CRO that offers more.

What should a good FIH quote show you?

Once the inputs are in, judge the quote by its structure. A serious FIH quote has three buckets:

1. Site costs. Investigator and hospital payments per the schedule of events. These are pass-throughs negotiated at the clinical trial agreement — the CRO should show them transparently, not bury them.
2. CRO professional fees. Project management, monitoring, regulatory, data management. This is the bucket with flexibility — it is what the CRO controls.
3. Third-party pass-throughs. Labs, imaging, couriers, translations, EDC hosting. The CRO does not control these costs but should influence them through negotiation — and every one should be auditable against invoices.

Two more honesty tests: the quote should state its assumptions explicitly (patient count, visit numbers, timelines), and it should require an advance payment to start work — standard in the industry, because startup costs are real and immediate. A quote with no assumptions and no advance is not a quote; it is a marketing document.

The sponsor's pre-quote checklist

Before you ask any CRO for a number on your first-in-human study, assemble this package. It is the difference between a quote you can budget against and a conversation you will have twice.

1. Protocol or detailed synopsis. Final if you have it; near-final with flagged open points if you do not. Flag what is still changing — it affects the quote's shelf life.
2. Schedule of events. Visit-by-visit table: assessments, procedures, and timing for every patient contact from screening through last follow-up.
3. Patient count and cohort structure. Total enrollment target plus any dose-escalation or staged-cohort design.
4. Patient type definition. Indication, key inclusion/exclusion criteria, and any recruitment constraints you already know about.
5. Target timelines. When you need startup complete and first-patient-in — and which date is real versus aspirational.
6. Country preferences or constraints. Any markets already chosen or ruled out, and why.
7. Budget signals. A range you need to land in is not a weakness; it lets the CRO design to it or tell you honestly that it cannot be done.
8. Decision process and timeline. Who decides, and when. It focuses everyone's effort where it matters.

Frequently asked questions

Can you give me a ballpark quote from just the synopsis?

Yes — a rough range, honestly labeled as one. Precision needs the full package: protocol or synopsis, schedule of events, and feasibility questionnaire answers. Treat any 'precise' number built from a synopsis alone as fiction.

Why do you need the schedule of events to quote accurately?

Because every cost line derives from it: site payments, monitoring visits, hospital and lab pass-throughs, and CRO effort. Two similar synopses can hide very different schedules of events — and very different budgets.

What is the feasibility questionnaire for?

It converts the protocol into operational facts: patient type, activities, visit structure, patient count, and timelines. It is also where unrealistic assumptions surface before they become contract disputes.

How long does a precise quote take once we send everything?

That depends on the CRO and the study's complexity — but the clock starts when the full package arrives, not when the first email was sent. Sending a partial package and asking 'how much longer' restarts nothing; it just delays the start.

Should we get quotes from multiple CROs?

Yes — and give every CRO the same package. Quotes built from different inputs are not comparable, and the cheapest number built from the thinnest inputs is usually the most expensive study.

What if our protocol is still changing?

Say so upfront. A good CRO will quote against the current version, flag the assumptions, and tell you which changes would move the number. Quoting against a moving protocol without flagging it helps no one.

Send the package, get a number you can use

What your CRO needs to quote your first-in-human study is the full package: protocol or synopsis, schedule of events, and feasibility answers. Send bioaccess® yours and you will get a structured, three-bucket quote with explicit assumptions — a number you can take to your board.

Talk with bioaccess® about your Latin America FIH strategy

Regulatory references

• bioaccess® blog: First-in-Human Trial Budgets in Latin America: What the Money Actually Buys — and Where You Can Cut (2026).
• bioaccess® blog: First-in-Human Clinical Trial: What Happens in Each of the Nine Workstreams (2026).
• bioaccess® blog: How We Qualify FIH Sites and Investigators in Latin America (2026).
• ICH E6 Good Clinical Practice (GCP).

PRACTICAL GUIDE | 2026

Bilingual Physician Project Managers: How FIH Studies Are Actually Staffed in Latin America

In first-in-human, the person running your study should be a doctor.

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

Ask who will run your study day to day, and most CRO proposals answer with a title: 'project manager.' Ask what that person is trained in, and the answers get vaguer. In first-in-human research — the first time a device or drug is tested in people — that vagueness is a risk. Bilingual physician project managers are how FIH studies are actually staffed at bioaccess®: every study gets a project manager who is a physician, fully bilingual, supported by physician assistants, with weekly sponsor meetings built in. Nothing less than physicians.

This is not a brochure claim; it is an operating standard, and it is the reason this post is framed as five questions to ask any LATAM CRO about staffing. Use them on us too.

Why does physician-led management matter in first-in-human?

FIH studies are where the unknowns live. The protocol is being executed for the first time in humans, safety signals are ambiguous by definition, and the investigator needs a counterpart who can think clinically — not just track milestones. Three reasons a physician project manager changes the study:

1. Safety judgment in real time. When an unexpected event occurs, a physician PM triages it clinically before it becomes a reporting question: is this plausibly device-related, what does the investigator need to know right now, and what cannot wait until Monday. Process knowledge matters; clinical judgment matters more.
2. Peer credibility with investigators. Principal investigators are physicians. A physician PM speaks to them as a peer — about the procedure, the anatomy, the risk — which is a different conversation than a status update. That credibility is what keeps investigators engaged when enrollment gets hard.
3. Protocol interpretation under ambiguity. First-in-human protocols encounter situations the writers did not foresee. A physician PM interprets intent, not just text, and knows when a deviation needs an immediate safety conversation versus a documented note.

What does 'fully bilingual' actually buy you?

Bilingual here means working-level fluency in both directions, not a translation app and good intentions. The physician PM reads the source protocol in English, works with sites in Spanish or Portuguese, and reports to the sponsor in English — with nothing lost between those steps. In practice that means:

• Site conversations happen in the investigator's language, at full clinical depth.
• Sponsor updates arrive in English, with nuance intact — not filtered through a translator's summary.
• Safety discussions do not wait for an interpreter to become available.
• Documents are reviewed by someone who understands both the language and the medicine.

Weekly sponsor meetings are the cadence that holds it together: a standing touchpoint where enrollment, safety, and roadblocks are reviewed with the people who can act on them. In FIH, a week is a long time to go without one.

What does the full FIH staffing model look like?

The physician PM does not work alone. The standard team around a Latin America FIH study:

ICH-GCP is the International Council for Harmonisation's Good Clinical Practice — the international quality standard every role above works to. The point of the table: clinical depth sits at the top of the team, not somewhere in an advisory footnote.

5 questions to ask any LATAM CRO about staffing

Use these verbatim in your next CRO evaluation. The answers — and the pauses before them — tell you how your study will actually be run.

1. Who exactly will be my day-to-day project manager, and what is their medical training? You want a name and a degree, not a role description. 'A senior PM will be assigned' is not an answer.
2. Is the PM a physician — and is that standard or a premium? If physician leadership costs extra, physician leadership is not the company's standard. Ask what the non-physician alternative looks like.
3. Is the PM fully bilingual, and in which direction does information flow? Test it: ask how a safety discussion with a Spanish-speaking investigator reaches the English-speaking sponsor, and how fast.
4. Who supports the PM, and what happens when they are unavailable? Physician assistants providing clinical backup is the answer you want. A single point of failure with no clinical backup is the answer you fear.
5. How often do we meet, and who from your side attends? Weekly sponsor meetings with the physician PM attending should be the baseline. Monthly status decks are not study management.

Frequently asked questions

Why do FIH studies need physician project managers specifically?

Because first-in-human is where clinical ambiguity is highest: unexpected events, protocol situations nobody foresaw, and safety signals that need clinical triage before they become reporting questions. A physician PM brings judgment a process manager cannot.

Is a bilingual physician PM standard at bioaccess or an upgrade?

Standard. Every FIH study gets a bilingual physician project manager plus physician assistants and weekly sponsor meetings. It is the baseline, not a premium tier.

What does 'fully bilingual' mean in practice?

Working fluency in both directions: the PM works with sites in Spanish or Portuguese and reports to sponsors in English, with clinical nuance intact — including in real-time safety discussions, where waiting for an interpreter is not an option.

What is the difference between physician assistants and administrative support?

Physician assistants are physicians who provide clinical depth beneath the PM: site support, medical review, backup coverage. They extend the clinical leadership of the team; they do not file paperwork.

How often should we expect to hear from the study team?

Weekly, at minimum, in a standing sponsor meeting with the physician PM — covering enrollment, safety, and roadblocks. In FIH, anything less frequent is a gap, not a cadence.

Does physician-led staffing cost more?

It is built into the CRO's professional fees as the operating standard — not priced as an add-on. When comparing CRO quotes, check whether clinical leadership is in the baseline or hiding in an optional line item.

Meet the physicians who would run your study

Bilingual physician project managers are how FIH studies are actually staffed at bioaccess® — every program, every country, as standard. Ask us the five questions above, then ask our competitors. The comparison will be instructive.

Talk with bioaccess® about your Latin America FIH strategy

Regulatory references

• ICH E6 Good Clinical Practice (GCP) — the standard all study staff operate under.
• bioaccess® blog: First-in-Human Clinical Trial: What Happens in Each of the Nine Workstreams (2026).
• bioaccess® blog: How We Qualify FIH Sites and Investigators in Latin America (2026).
• bioaccess® blog: What Happens After First-in-Human (2026).

PRACTICAL GUIDE | 2026

Get the class and grouping right before you build the dossier.

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.

The short version

Risk classification is not a label you carry from the United States or Europe into Latin America. It is a country-specific regulatory decision that determines the registration route, grouping architecture, supporting evidence, fees, timing, and even which products can share one filing. Make that decision before translation and dossier assembly—not after an agency asks you to split the application.

Classification derails filings before the dossier does

When a medical-device registration stalls in Latin America, the instinct is to blame the dossier: a missing certificate, a bad translation, or an incomplete technical file. In practice, the more expensive mistake often happens earlier. The product was classified or grouped incorrectly before the dossier was built.

bioaccess® recently developed a Colombia-and-Peru registration strategy for a US electrosurgery manufacturer's full device line. The portfolio included generators, monopolar and bipolar instruments, reusable and single-use variants, neutral plates, cables, footswitches, and a factory kit. The hard question was not whether the documents existed. It was which products could legally share a registration—and why.

That distinction matters. A classification error can change the application type, evidence requirements, grouping logic, government fees, review clock, and number of registrations. If the error is found after filing, the sponsor may face an agency requirement, a forced split, or an entirely new submission.

Rule No. 1

Do not assume a US Food and Drug Administration product code or a European Union Medical Device Regulation class maps one-to-one onto a Latin American class. Each authority applies its own rules, definitions, intended-use analysis, and grouping criteria.

The country map: similar class numbers, different consequences

Use this as an orientation map, not as a substitute for a device-specific classification memo. The intended purpose, duration of use, invasiveness, active function, anatomy, and combination with other products can change the outcome.

Colombia: classification changes the procedure, not just the label

Decreto 4725 de 2005, as amended, establishes Classes I, IIa, IIb, and III in Article 5. Article 7 contains the 18 classification rules. Article 6 sets the implementing principles: intended purpose governs; products used in combination are classified separately; accessories are classified separately from the parent device; software that drives a device takes that device's class; and when several rules apply, the strictest rule governs.

The commercial consequence is immediate. Class I and IIa registrations proceed under Colombia's automatic-registration regime. Class IIb and III products receive a full technical evaluation. If the class is wrong, the sponsor has selected the wrong procedure—not merely the wrong box on a form.

Grouping requires equal care. Article 28 permits several devices to share a sanitary registration when they have the same risk classification, use, and generic denomination, and it addresses systems and kits used together. Under INVIMA's current grouping circulars—including Circular 5000-0001-22 and Circular 500-3052-16, subject to confirmation that they remain in force—exclusive parts, accessories, consumables, and spare parts may sometimes be covered by the parent equipment's registration. Factory kits must be assessed under the rules for kits and systems, with the highest-risk component governing classification.

Peru: the approved family defines what you can add later

Peru uses four classes under D.S. 016-2011-SA, as amended and issued under Ley 29459: Class I (low risk), Class II (moderate risk), Class III (high risk), and Class IV (critical risk).

Do not treat family composition as flexible after approval. The approved registration defines the family's scope. Adding products that fall outside that scope generally requires a new registration or a formal modification that DIGEMID may reject. The practical rule is simple: decide the family architecture before filing, and document why every model belongs.

Brazil: the current rule is RDC 751/2022

Brazil retains Classes I through IV under ANVISA RDC 751/2022, in force since March 2023. Classes I and II proceed through notificação; Classes III and IV require registro. RDC 185/2001 is revoked and should not be used as the operative legal basis. A classification error therefore changes the regulatory pathway.

Mexico: check the low-risk list before building a registration

Mexico uses Classes I, II, and III under Article 83 of the Reglamento de Insumos para la Salud; the medical-device definition appears in Article 262 of the Ley General de Salud. COFEPRIS also publishes an Acuerdo listing certain low-risk products that do not require sanitary registration. Missing that list can waste a full registration effort. Mexico also provides an equivalence route for qualifying devices with United States Food and Drug Administration or Health Canada approval; confirm eligibility for the exact product and current procedure.

Argentina and Chile: confirm the procedural regime in force

Argentina uses Classes I through IV under ANMAT Disposición 2318/02 (texto ordenado 2004), as amended. Confirm the procedural dispositions and submission route that are current when the filing starts.

Chile recognizes Classes I through IV under Decreto Supremo 825/1998, but historically mandatory Instituto de Salud Pública registration has applied only to a listed subset of medical devices. Do not describe Chile as a comprehensive mandatory-registration market without checking the current list. Chile is moving toward a broader medical-device law, so sponsors must confirm the transition status immediately before acting.

Scope carve-outs

This guide addresses general medical devices. In Colombia, in vitro diagnostic devices are governed separately by Decreto 3770 de 2004; Brazil also regulates IVDs under a separate RDC. Software as a medical device follows specialized rules and should receive its own classification analysis.

Five mistakes that create preventable delay

1. Treating FDA or EU classification as portable

A 510(k) letter, FDA product code, or EU Medical Device Regulation certificate is evidence. It is not a Latin American classification decision. Start with the intended purpose and the local rules in each country. Then use the foreign authorization to support—not replace—the local analysis.

The same warning applies to grouping. A set of models organized as one European technical-file "family" is not automatically one INVIMA family, one DIGEMID family, or one ANVISA notification. The legal tests are different.

2. Mixing risk classes inside an ordinary family

In the electrosurgery project, the manufacturer's first instinct was to group Class I neutral plates with Class IIb active electrodes in one monopolar family. That may look logical from a catalog perspective. It is not an ordinary family under Colombia's Article 28, which requires the same risk classification for ordinary grouping.

Filing Class I and IIb products as one ordinary family creates a predictable risk: an INVIMA request or a forced split. A defensible alternative may be to place exclusive accessories and consumables under the generator's registration, using the equipment-with-exclusive-accessories route in INVIMA's current grouping rules. When accepted, those accessories can be imported and marketed under the equipment's registration number. The factual record must show that the accessories were designed and approved for use with that equipment.

3. Hiding a multi-function kit inside a device family

A factory kit can combine products that do not share one function or class. In the real project, a blepharoplasty kit included monopolar and bipolar instruments, neutral plates, and cables. That commercial reference could not simply ride inside the monopolar family.

If the manufacturer wants to market the kit as a named, factory-established reference, assess it as a kit or system under Colombia's Article 28 and the applicable INVIMA grouping circulars. A separate registration may be required. The highest-risk component governs classification—a principle also reflected in the approaches used in Brazil and Argentina. Do not assume that bundling products in one box makes them one device.

4. Splitting variants automatically—or grouping them without evidence

In Colombia, sterile versus non-sterile, or single-use versus reusable, variants of the same device do not automatically require separate registrations when intended purpose, generic denomination, and risk classification remain compatible. The distinction still needs technical support through labeling, sterilization or reprocessing validation, shelf life, and the instructions for use.

Do not export that conclusion to every market. In other countries, these variants can affect grouping, evidence requirements, and, under some rule sets, classification itself. Run the local analysis.

5. Letting the documents contradict the strategy

A sound classification can still fail if the source documents disagree. Before filing, reconcile the Certificate to Foreign Government or Certificate of Free Sale, CE certificate, instructions for use, labels, technical files, and declarations of conformity. The names, models, intended uses, indications, sterility status, reusability, and claimed class must match the filing architecture.

Legalization, apostille, and validity-period problems for CFS/CFG and ISO 13485 certificates generate agency questions just as often as content inconsistencies. Check both substance and formal validity.

In the electrosurgery project, a reissued CE certificate added devices and changed the filing scope. But a model newer than the current CFG could not enter the submission merely because it appeared on the CE certificate. Those stock-keeping units became fileable only when the supporting market-authorization certificate was reissued to include them. One updated document does not cure a mismatch across the set.

Before you file: a classification and consistency check

Complete this review before translation, legalization, pricing, or submission. If any answer is uncertain, stop and resolve it before the dossier hardens around the wrong strategy.

• Freeze the intended purpose. Use one approved statement across the IFU, labels, certificates, technical file, and application.
• Classify country by country. Document the local rule, the facts that trigger it, and why stricter competing rules do or do not apply.
• Classify accessories separately. Then determine whether exclusive accessories qualify to sit under the equipment registration.
• Build a model-level matrix. List every catalog number, generic name, intended use, class, sterility, reusability, and proposed registration.
• Test every family. Confirm the models meet the local tests for class, use, generic denomination, design, and presentation.
• Test every kit. List each component and class; identify the highest-risk component; decide whether the named kit requires a separate registration.
• Reconcile every source document. Match product names, models, indications, class, sterility, and reusability across the CFG/CFS, CE certificate, IFUs, labels, technical files, and declarations.
• Check formal validity. Confirm issuer, validity period, legalization or apostille, and required translations for the CFS/CFG and ISO 13485 certificate.
• Verify the current procedure. Confirm that the law, agency circulars, low-risk lists, equivalence routes, and transition rules are still in force on filing day.
• Write the rationale. Keep a short classification-and-grouping memorandum in the submission file so the strategy can survive agency scrutiny and later portfolio additions.

The operating principle

Classification first. Grouping second. Document reconciliation third. Translation and filing come after all three are stable. Reversing that order turns a regulatory judgment into expensive rework.

Build the registration architecture before the agency does it for you

bioaccess® helps medical-device companies classify, group, and register portfolios across Latin America. Our Medical Device Registration & Market Access team supports ANVISA, INVIMA, COFEPRIS, ANMAT, ISP, and DIGEMID strategies—from the first model matrix and document-gap review through local representation, submission, and post-market requirements.

If your portfolio includes multiple models, accessories, kits, sterile and reusable variants, or certificates that do not line up perfectly, resolve the architecture before filing. A short strategy review now is cheaper than a forced split later.

Talk with bioaccess® about your Latin America registration strategy

Regulatory references

• Colombia: Decreto 4725 de 2005, as amended; Decreto 3770 de 2004 for in vitro diagnostics; applicable INVIMA grouping circulars, including 5000-0001-22 and 500-3052-16, subject to confirmation that they remain in force.
• Peru: Ley 29459; Decreto Supremo 016-2011-SA, as amended.
• Brazil: ANVISA RDC 751/2022 for general medical devices; separate regulation applies to in vitro diagnostics.
• Mexico: Ley General de Salud, Article 262; Reglamento de Insumos para la Salud, Article 83; current COFEPRIS low-risk Acuerdo and equivalence procedures.
• Argentina: ANMAT Disposición 2318/02 (texto ordenado 2004), as amended, together with current procedural dispositions.
• Chile: Decreto Supremo 825/1998; current Instituto de Salud Pública mandatory-registration list and medical-device-law transition materials.

Last verified: September 2026

This guide is general information only and does not constitute legal or regulatory advice. Agency rules, circulars, lists, and procedures change frequently; confirm your strategy with qualified regulatory counsel before relying on it. Mike provides decision-support and is not a licensed attorney.