How Much Preclinical Testing Do You Need for a First-in-Human Trial in Latin America?

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First-in-human trials · Preclinical strategy · Latin America

How much preclinical testing do you need?

A medtech CEO recently asked us the question we hear most often: “What preclinical testing do we actually need to get our first-in-human study approved in Chile or Panama — and can we defer some of it?” Here is the honest answer, plus the proof from a knee implant taken through approval in Colombia and the Dominican Republic.

Regulatory guide

Reviewed 29 September 2026

Chile · Costa Rica · Panama · El Salvador

General information, not legal advice

September 29, 2026

16

min read

By

Julio G. Martinez-Clark, CEO, bioaccess®

The short answer

There is no universal checklist. The working standard, in practice, is “preclinical testing as applies to the device” — the evidence a reasonable reviewer needs to believe your device will not harm the patients in the study.

Since 2010

Running first-in-human programs across Latin America — and never had a trial rejected for lack of preclinical testing.

In this guide

The question behind the question

Functional/efficacy vs. biocompatibility

Four countries, two approval models

What committees actually ask for

Yes, you can defer testing

The proof: a knee implant

The staged path sponsors take

Why not just do it in the US?

FAQ

Key sources

Add this insight to your email

Copy a concise sponsor-ready paragraph based on the article.

The question behind the question

On a recent call, the CEO of a US orthopedic startup walked us through his dilemma. His company has a novel knee implant. They have completed a pilot animal study, fatigue testing, and cadaver work. A GLP (good laboratory practice) animal study is underway, with a three-month endpoint expected at the end of October. Biocompatibility and sterilization work is in progress.

His questions were the ones every first-in-human sponsor eventually asks:

1. What preclinical testing do Chile and Panama actually require for a first-in-human approval?
2. Can we defer some of the testing we planned for a US Early Feasibility Study and still get approved?
3. Can we show an ethics committee what we have already done and ask what else they want — before we commit to a country and a site?
4. Will you review our existing package and tell us, honestly, whether it is enough — before we spend money on site selection?

This article answers all four. And a note on why we wrote it: we are not aware of any comparable country-specific published guide to preclinical requirements for Latin American first-in-human device trials. This one draws on the actual rulebooks — Chile’s, Costa Rica’s, Panama’s, and El Salvador’s — plus what we have learned running first-in-human programs in the region since 2010.

The short answer: “preclinical testing as applies to the device”

There is no universal checklist. Latin American regulators and ethics committees do not publish a fixed list of required preclinical tests the way a US IDE (investigational device exemption) submission implies. The working standard, in practice, is preclinical testing as applies to the device — the evidence a reasonable reviewer needs to believe your device will not harm the patients in the study.

That sounds vague. In practice, it is liberating, because the review is a conversation, not a box-checking exercise. But “no checklist” does not mean “no rules.” Each country has a defined approval gate, a defined dossier, and — in Chile’s case — an explicit expectation that preclinical and risk work be exhaustive at the first-in-human stage. The rest of this article maps both: the gates and the evidence.

Do we need a functional/efficacy animal study, or is biocompatibility enough?

This is the question behind half the preclinical debates we see — a second sponsor asked us exactly this the same month — so it deserves its own answer. Two different questions get conflated here, and they need separating:

Question 1: GLP or non-GLP? That is about the quality system wrapping the study — good laboratory practice versus a scientifically sound study run without formal GLP certification. (More on this below.)

Question 2: biocompatibility or functional/efficacy? That is about what the study is designed to prove. Biocompatibility testing (the ISO 10993 series, the international standard for biological evaluation of medical devices) answers “does the material harm tissue?” A functional or efficacy animal study answers a different question: “does the device work as intended inside a living system?” A permanent implant usually needs both questions answered. A transient, non-implantable device might not.

No rulebook we reviewed answers Question 2 with a blanket yes or no — and that is the honest, citable position:

• El Salvador’s official device guidance (published in the regulator’s own journal) lists preclinical evidence as a menu of device-dependent options: performance and function tests in animal models, mathematical models, in vitro organ and tissue tests, and technical-specification measurements appropriate to the device type. Biocompatibility studies per ISO 10993 apply “depending on the nature of the device”; sterilization validation applies “when applicable.” The same guidance frames first-in-human studies as pilot or exploratory work for the questions preclinical testing can no longer answer. (SRS, ConSciencia Sanitaria)
• Panama’s framework sets a process and a documentation package, not a preclinical checklist. No official source imposes a categorical functional or efficacy animal-study requirement or a large-animal model mandate — but equally, no official source says biocompatibility plus bench testing is automatically sufficient. Adequacy is judged on the protocol’s safety and risk-benefit justification, assessed by the accredited ethics committee and, for higher-risk protocols, by the Ministry of Health’s technical evaluation. (MINSA research-regulation hub)

The bottom line: whether biocompatibility plus bench testing is enough, without a functional animal study, is device-specific and cannot be settled from the rulebook alone. It is settled through a documented inquiry with the reviewers before you file — which is exactly what the gap-analysis process below is for.

Four countries, two approval models

It helps to understand who you are actually convincing. The four countries cluster into two models — and in neither model is the ethics committee the only gate, whatever older summaries may suggest.

Model 1 — The ethics committee leads; the health authority authorizes

In Chile and Costa Rica, your scientific conversation happens with an accredited ethics committee, but approval is not complete without a second, ministry-linked step.

• Chile requires three things: a favorable opinion from an accredited Comité Ético Científico (CEC, scientific ethics committee); an “autorización especial para uso provisional” (special authorization for provisional use) from the Instituto de Salud Pública (ISP, the Institute of Public Health); and authorization from the director of the research site. The ISP authorization is not optional and not a notification — it is legally required by Article 111A of the Código Sanitario (Sanitary Code), added by Ley 20.850: products and medical devices used in human research “deberán contar con una autorización especial para su uso provisional, otorgada por el Instituto de Salud Pública.” It is filed after ethics approval, with the protocol, the informed-consent format, and the insurance policy, and it is valid for a maximum of one year, renewable. (Código Sanitario, Art. 111A) The committees themselves are accredited by the Ministry of Health (MINSAL) under Norma Técnica 0151, with accreditation granted by the regional health authority. Chile’s current device-investigation guide — published by the ISP in September 2025 — states plainly that at first-in-human and preliminary-viability stages, “se debe poner énfasis en las pruebas preclínicas / no clínicas y en las de evaluación de riesgos (las que deben ser exhaustivas)”: preclinical and risk-assessment testing must be exhaustive. Risk management follows NCh-ISO 14971 (the Chilean adoption of the international risk-management standard), and the investigator’s brochure (IB) follows NCh ISO 14155 Annex B (the clinical-investigation standard). Note that the ISP describes its guides as non-binding support documents — but they are the clearest statement of what reviewers expect. (ISP Guía de Investigación Clínica de Dispositivos Médicos en Humanos, Sept 2025)
• Costa Rica is a two-gate system by statute: approval from a CONIS-accredited ethics committee (which must decide within one calendar month), plus mandatory inscription with CONIS (Consejo Nacional de Investigación en Salud, the National Health Research Council) — including a technical good-clinical-practice review and a formal CONIS resolution — before any human enrollment. CONIS sits attached to the Ministry of Health. (Ley 9234; CONIS requirements) The dossier is codified: protocol plus Spanish translation, investigator’s brochure, an IDE (investigational device exemption) or equivalent approval letter from FDA, EMA (the European Medicines Agency), or another recognized agency, device classification, GMP (good manufacturing practice) and sterility certificates, insurance — and, for preclinical evidence, a summary of all prior preclinical and clinical studies plus the IB. No GLP mandate appears anywhere in the law or its reglamento.

Model 2 — The regulator and the ethics committee each review

In Panama and El Salvador, both a health regulator and an ethics body have a defined role.

• Panama runs on Ley 84 of 2019, implemented for clinical research by Decreto Ejecutivo 21 of April 2026 (published in Gaceta Oficial 30510-C). The pathway has three gates: institutional conformity where applicable; registration on RESEGIS (Registro de Investigaciones para la Salud, the national health-research registry) with the Ministry of Health’s research-regulation unit — complete files within days, higher-risk protocols within 30 calendar days; and ethics approval from a Comité de Bioética de la Investigación (CBI, research bioethics committee) accredited by the Comité Nacional de Bioética de la Investigación (CNBI, the national bioethics council). The Ministry’s act is registration plus a technical and public-health evaluation — not an ethics approval. (MINSA research-regulation hub) An investigational device also needs an exception from sanitary registration, supported by the CBI-approved protocol in Spanish. What the rulebook does not contain is any published animal-study quota, species or duration requirement, or GLP mandate.
• El Salvador requires regulatory authorization of the clinical investigation by the Superintendencia de Regulación Sanitaria (SRS, the Health Regulation Superintendency) — which succeeded the Dirección Nacional de Medicamentos (DNM, the former National Medicines Directorate) in August 2024 — plus a favorable opinion from the Comité Nacional de Ética de la Investigación en Salud (CNEIS, the National Health Research Ethics Committee). The SRS’s statutory hook is explicit: it authorizes “la experimentación, el desarrollo e investigación clínica” of medical devices. (Ley de la Superintendencia de Regulación Sanitaria; CNEIS) Official materials document both reviews but do not establish that they run simultaneously, so we do not describe them as parallel — we say SRS authorization plus CNEIS favorable opinion. CNEIS approvals are valid for one year and renewable.

Either way, the scientific conversation happens with clinicians and ethicists asking one question: is there enough evidence that this device is safe to test in humans?

What committees actually ask for

Here is what more than a decade and a half of first-in-human work in the region has taught us. Read every line below as our experience, not as a quotation from any rulebook:

• In our experience, GLP animal studies are not required as a rule. No country’s device framework we reviewed publishes a GLP mandate for animal studies — Chile’s guide, Ley 20.120, and its reglamento never mention GLP; Panama’s framework is silent; El Salvador’s official guidance requires “adequate, device-specific” nonclinical evidence without a GLP clause; Costa Rica’s law is silent. And in practice, committees accept well-designed non-GLP or GLP-like studies, provided the science is sound and the model is relevant. The requirement is evidence of safety, not a quality-system label on every study.
• The package is device-specific. A permanent orthopedic implant needs different evidence than a transient catheter. Fatigue testing, biocompatibility, sterilization validation, and an animal model relevant to the anatomy in question are the typical pillars — but the exact mix is judged against your device, not a template. El Salvador’s guidance says this explicitly; everywhere else, it is how reviewers behave.
• The burden is persuasion, not compliance. Your job is to show the committee that patients will not be harmed. A coherent story — bench testing plus a relevant animal model plus a clear risk analysis — beats a thicker binder of irrelevant tests.

We will say it plainly, as a statement about our own programs: since 2010, across our first-in-human trials in Latin America, we have never had a trial rejected for lack of preclinical testing. That is not because the bar is low. It is because the bar is sensible — and because we find out what each committee wants before we file.

Yes, you can defer testing

This was our caller’s most important question, and the answer is yes — with a process around it. This is our professional judgment, not a regulatory guarantee.

The US Early Feasibility Study pathway front-loads enormous preclinical requirements. In Latin America, you can sequence differently: get to first-in-human approval with the evidence that matters for patient safety now, and complete the remaining testing in parallel with the trial or ahead of your FDA submission.

The way to do this responsibly is a gap analysis before you commit. After engagement, we review your full documentation package — every test report, protocol, and dataset — and produce a checklist: what you have, what the reviewers will likely want, and what can wait. Then we take that checklist into pre-submission conversations with the reviewers themselves, so you are hearing it from the decision-makers, not guessing.

A note on those conversations, because precision matters here: no country in this article publishes a formal pre-submission or scientific-advice procedure for device trials. What exists is working practice — in our experience, Chilean and Costa Rican committees will typically discuss your package informally before you file — plus, in El Salvador, a standing official commitment by the regulator to provide technical advice and support on request. We treat these as working conversations that de-risk the filing, not as binding rulings.

That is the answer to question three as well: yes, you can show the reviewers what you have done and ask what else they need. In the committee-led countries, that conversation happens before you have spent a dollar on site contracts.

The proof: a knee implant approved in Colombia and the Dominican Republic

The closest program we have run to our recent caller’s device is Sparta Biomedical’s ORMI-CFC — a novel knee implant out of the orthopedic world.

Per bioaccess program files, Sparta’s preclinical package centered on a 13- and 26-week functionality and biocompatibility study in a sheep knee model, run under GLP at Colorado State University’s preclinical surgical research laboratory. That animal work, together with the device’s bench testing, was the evidentiary core of the submissions. (Study details in this section come from our program files, not from a public disclosure.)

bioaccess secured first-in-human trial approvals for the program in Colombia (through INVIMA, the national regulatory agency) and the Dominican Republic, and the study enrolled and treated patients in both countries, at sites in Bogotá and in Santiago.

Two things worth noting. First, the package that won approval was built around the single most relevant question — does this implant function safely in a living knee? — not around an exhaustive battery of every test imaginable. Second, the approval pathway worked exactly as described above: a device-appropriate evidence package, presented to the reviewers that actually decide, with no demand for testing beyond what the science required.

The staged path most sponsors take

Our caller also asked about sequencing the business side: can you get to approval as a fundraising milestone, then raise more capital before running the study? Yes — and it is the most common structure we see.

The typical phasing looks like this:

1. Documentation review and gap analysis. We review everything you have and produce the checklist.
2. Pre-submission conversations. Where the framework allows — routinely in our experience in Chile and Costa Rica, and through the regulator’s technical-advice commitment in El Salvador — we take the package to the reviewers and confirm what is needed.
3. Investigator and site selection. Only now do you invest in the country and site.
4. Submission and approval. The ethics committee (and where applicable, the regulator) reviews and approves.
5. Fundraise on the approval. An approved first-in-human trial in hand is a concrete milestone for investors.
6. Run the study once the next round is closed.

Work is structured in milestone-based phases, so you are never funding the entire program before you know the answer to the only question that matters: will they let us treat patients?

Why not just do it in the US?

The US Early Feasibility Study pathway was designed with good intentions, and FDA’s Breakthrough Devices Program and its Total Product Life Cycle (TPLC) Advisory Program (TAP) pilot — the voluntary program through which FDA’s device center gives early, frequent strategic engagement to developers of important devices (fda.gov) — have helped. But the practical reality our sponsors report is different: at large US health systems, securing institutional review board (IRB) approval alone can take eight or nine months, and the institutional risk appetite for truly first-in-human work keeps shrinking. You can easily spend a year and a seven-figure budget before a single patient is treated — and the preclinical bar keeps rising while you wait. (Those US figures are sponsor-reported experiences, not regulatory timelines.)

Latin America does not run on one clock, so here are the country-specific ones: Chile’s committee review typically runs on a roughly 45-day clock, followed by the ISP’s provisional-use authorization; Costa Rica pairs a one-month committee decision with the mandatory CONIS inscription before enrollment; Panama’s full pathway typically runs three to four months; El Salvador’s reviews run on roughly 30-day cycles. One caution on older numbers you may see quoted, including our own from a few years ago: the rules have modernized since 2022 — Chile published a new ISP device-investigation guide in September 2025 and notified the WTO (World Trade Organization) of a further authorization guide in June 2026 — so older timelines no longer describe the process. The committees are experienced with first-in-human device work, and the data has supported subsequent FDA submissions. That is the arbitrage: not lower standards, but a saner process.

Frequently asked questions

Do Chile and Panama require GLP animal studies for first-in-human approval?

No country’s device framework we reviewed publishes a GLP requirement for animal studies. In our experience, ethics committees accept non-GLP or GLP-like animal studies, provided the study design is scientifically sound and relevant to the device. (Related reading: Does Panama require functional large-animal studies for a medical device FIH?) The requirement is evidence of safety, not a specific quality-system label on every study.

Is biocompatibility testing enough, or do we need a functional animal study?

It depends on the device — see the full section above. Biocompatibility (ISO 10993) and functional/efficacy work answer different questions, and no rulebook settles the mix with a blanket rule. El Salvador’s official guidance treats animal performance and function models as device-dependent options; Panama’s framework leaves the call to the protocol’s risk-benefit justification. The way to resolve it is a documented inquiry with the reviewers before filing.

Can we defer some preclinical testing until after first-in-human approval?

Yes, in our judgment. Testing that is not essential to the patient-safety judgment can typically be completed in parallel with the trial or ahead of a later FDA submission. A gap analysis identifies what is needed now versus what can wait.

Can we get the reviewers’ read on our package before committing to a country and site?

In our experience, yes. Chilean and Costa Rican committees will typically discuss your package informally before you file, and El Salvador’s framework commits the regulator to technical advice on request. No country publishes a formal pre-submission procedure for device trials, so treat these as working conversations — but they happen before you have spent money on site contracts.

Will you review our existing testing before we spend money on site selection?

Yes. Documentation review and gap analysis come first — before site search, before site contracts. You should never invest in a country or a site and then discover a missing test.

What did the preclinical package look like for a real orthopedic first-in-human trial in the region?

Per bioaccess program files, Sparta Biomedical’s ORMI-CFC knee implant was approved for first-in-human trials in Colombia and the Dominican Republic on the strength of a 13- and 26-week sheep knee-model functionality and biocompatibility study (run under GLP at Colorado State University) plus the device’s bench testing. The package was built around the relevant safety question, not an exhaustive test battery.

bioaccess® is a first-in-human contract research organization (CRO) running early-stage medical device trials across Latin America and the Caribbean, anchored to US FDA strategy. If you are weighing what your device needs before first-in-human, start with a documentation review — it is the cheapest question you will ever answer.

Key sources

• Código Sanitario, Art. 111A (Chile) — special authorization for provisional use in research, via Ley 20.850.
• ISP, Guía de Investigación Clínica de Dispositivos Médicos en Humanos (Sept 2025) — Chile’s device-investigation guide.
• Ley 9234 and CONIS requirements (Costa Rica).
• Ley 84 (2019) and Decreto Ejecutivo 21 (2026) via MINSA (Panama).
• Ley de la Superintendencia de Regulación Sanitaria and ConSciencia Sanitaria device article (El Salvador).
• FDA, Total Product Life Cycle (TPLC) Advisory Program (TAP).
• Julio G. Martinez-Clark, “How Chile Is Shaping Medical Device Clinical Trials in Latin America,” Med Device Online (on Chile’s MINSAL-accredited research ethics committees).
• See also: Chile & Costa Rica: ethics-committee approval on this blog.

Sources checked September 29, 2026. Regulatory texts linked inline. Case-study details from bioaccess program files.

This regulatory guide reflects sources reviewed as of 29 September 2026. Regulatory practice changes; verify the current official text before making a filing decision. General information only, not legal advice.

Start with the cheapest question.

bioaccess reviews your documentation package before you spend a dollar on site selection — and tells you honestly whether it is enough for first-in-human approval.

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