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What preclinical testing do I need to run a medical-device trial in Latin America?

Written by

Julio Martinez-Clark

in

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The question on almost every first-in-human and early-feasibility device call is the same: what preclinical testing do I need to run a medical-device trial in Latin America? Sponsors want a 21 CFR Part 58 list. Latin America does not publish one.

The region answer, already on the live bioaccess® GLP / early-feasibility guide, is this: Brazil, Panama, and El Salvador accept R&D-grade (non-GLP) preclinical data for early-feasibility device studies. The file that gets read is a coherent risk-benefit narrative — an ISO 14971 risk-management file plus an investigator’s brochure — not a GLP stamp. Country pages are cuts of that answer. The Panama cut is already live at how much animal / preclinical data for a Panama FIH. Do not duplicate it here.

This page does not prescribe a required animal n, species, or duration for a named device. Device class, contact duration, and the specific ethics committee still decide.

What “enough” means in official text

Chile’s Agencia Nacional de Dispositivos Médicos published the official Guía de Investigación Clínica de Dispositivos Médicos en Humanos. Buenas Prácticas Clínicas (ANDIM, May 2026; linked from ANDIM’s technical-guides page). Principle 3(d) of that guide is the gate in one sentence: the clinical and non-clinical information available on the investigational product must be sufficient to support the proposed clinical investigation. The guide does not name GLP, BPL, or 21 CFR Part 58.

For first-in-human and preliminary-feasibility stages, the same official guide puts the weight on preclinical / non-clinical testing and on risk evaluation, and it says those evaluations must be exhaustive. Traditional feasibility and pivotal work can add clinical data. The investigator’s manual (Manual del Investigador) exists to give the principal investigator enough safety and performance data from preclinical or clinical investigations to justify human exposure. Design justification is based on the preclinical data plus a clinical evaluation. Risk is estimated under ISO 14971 (Chilean NCh-ISO 14971:2022). The “informe de análisis de riesgo” is defined as the set of clinical and non-clinical data relevant to evaluating the device in humans.

ANDIM also writes the limit we keep on this page: given the diversity of devices and risks, the guide does not claim to be a comprehensive, device-specific testing menu. That is the official “show us what convinces you it is safe” posture — not a consultancy line.

Panama’s current clinical-research rulebook is Decreto Ejecutivo No. 21 of 23 April 2026 (Gaceta Oficial No. 30510-C), which implements Titles III and IV of Ley 84 of 14 May 2019. Both instruments are listed on MINSA’s official Regulación de Investigación para la Salud page. The live Panama cut already records what that rulebook does not add: a required animal n, species, or duration, and a hidden GLP animal mandate. Read the Panama page for the country file. This page is the region parent.

Brazil, Panama, El Salvador — the early-feasibility cut

The live GLP / GMP / sterility guide is the published bioaccess® operational record for early-feasibility device studies we have run. Three countries accept R&D-grade (non-GLP) preclinical data:

  • Brazil. For early-feasibility studies not intended for local market clearance, the published path is CEP (institutional ethics) under Law 14.874/24 and RDC 837/2023. CEP reviews scientific merit, risk-benefit, consent, and investigator fit. It does not apply a rigid GLP checklist. The same fact is restated on the live Brazil clinical-trials hub. ANVISA’s open-data directory at dados.anvisa.gov.br/dados/ publishes device-queue metrics and the registered produto-para-saúde catalog. It does not publish a device-trial registry. Do not invent one. Device clinical investigations (DICD) are petitioned; they are not an open trial list.
  • Panama. Ethics-committee-driven through the Comité Nacional de Bioética de Investigación (CNBI) and the institutional committee. R&D-grade data is accepted with an ISO 14971 file and an investigator’s brochure. ISO 13485 certification is not required for an investigational early-feasibility device; fitness-for-use documentation is enough. Country detail, including Decreto 21, sits on the Panama preclinical page and the Panama FIH guide. RESEGIS is the public health-research list (listprojects) — mixed protocols, not devices-only.
  • El Salvador. The same live GLP guide: the early-feasibility path does not require GLP-compliant preclinical data. Ethics committees evaluate the totality of the evidence — biocompatibility, mechanical performance, safety margins — against the proposed risk-benefit and the patient population. The current agency is the Superintendencia de Regulación Sanitaria (SRS), srs.gob.sv. Dirección Nacional de Medicamentos (DNM) is the older name. SRS’s public servicios page lists a device expediente and a clinical-trial submission platform. There is no public approved-protocol list. Do not claim one.

That published comparison also records what those three countries accept for the investigational unit itself: no ISO 13485 certificate as a hard early-feasibility gate, and verified (batch-level) sterility instead of a fully validated commercial sterilization process. Hospital infection-control review is often the real sterility gate. This page does not reopen that manufacturing argument; the GLP guide already holds it.

Colombia — INVIMA is a national-authority file, not a test menu

Colombia routes novel high-risk device investigations through INVIMA. The live GLP guide treats INVIMA as case-by-case and slower for truly novel devices without predicates (typical published clock 8–14 months). That is a pathway fact, not a preclinical quota.

What INVIMA does publish is a device-study inventory, not a required animal or GLP list. The official attachments under INVIMA investigación clínica de dispositivos médicos include the approved-study PDF (2021–October 2025) and the not-approved PDF for the same window. Those tables name acta, radicado, protocol title, investigational product, sponsor, CRO, ethics committee, site, and PI. They do not name a required n, species, duration, or Part 58 stamp. INVIMA’s public /estudios consulta is a medicine-trial search. Do not treat it as a device-trial dump.

The published “how much” example already on the FDA-acceptance FIH guide is the ReGelTec HYDRAFIL package that INVIMA and the independent ethics committee accepted: a 12-study GLP-where-applicable biocompatibility file compiled into a Biocompatibility Summary Report (ISO 10993 series, genotoxicity, chemical characterization and risk assessment). The same FIH guide says Latin American authorities do not prescribe a specific list of preclinical tests. The burden is on the sponsor to show the device is safe for first-in-human use. That published package is one accepted file. It is not a mandate for every Colombia or Latin America FIH.

Chile — official guidance, no public device-trial list

Use the May 2026 ANDIM guide above for the Chilean preclinical posture. ANDIM’s own home page, ispch.gob.cl/andim, still labels the studies platform “Plataforma de Estudios Próximamente.” There is no public Chilean device-trial registry to scrape. The medicine consulta at estudiosclinicos.ispch.gob.cl is not a device list. ISO 10993 appears in the official bibliography as Chilean NCh adoptions (NCh 2856/3 and NCh 2856/10) — genotoxicity / carcinogenicity / reproductive toxicity, and irritation / delayed hypersensitivity — not as a required animal n.

Mexico and Argentina — do not invent a device-trial preclinical menu

COFEPRIS public visors (medicines and the devices visor) are registro-sanitario search pages. They are not a first-in-human preclinical checklist and not a trial registry.

ANMAT’s downloadable estudios de farmacología clínica workbook is medicines. It is not a device-trial dump. This page does not invent a COFEPRIS or ANMAT device-FIH animal rule from those surfaces.

Public bioaccess® files already on the site

Reuse only what is already public:

  • ReGelTec HYDRAFIL — out-of-U.S. first-in-human work in Colombia and Panama (75 patients) later used toward CE Mark and an FDA IDE. Clinical-execution history. The preclinical package accepted by INVIMA is the 12-study GLP-where-applicable biocompatibility file on the FIH guide, not a large-animal quota for every device.
  • Axoft’s first-in-human brain-computer interface implantation in Panama, as already written on the Panama FIH guide: a novel device with no predicate, no prior human data, and R&D-grade preclinical testing. The ethics-committee path evaluated the risk-benefit narrative — investigator, monitoring, patient selection — rather than a GLP certification that did not yet exist for that device category.
  • Newrotex’s 15-day ethical approval in Panama for a first-in-human silk nerve guide, as already written on the FDA-acceptance FIH guide.
  • enVVeno’s early first-in-human clinical work in Latin America, as already written on the same FIH guide. The later FDA IDE is for a U.S. pivotal study; it is not a device clearance.

What to put in the investigator’s brochure

From the live early-feasibility guide, ethics committees in the recommended jurisdictions typically look for:

  • ISO 10993 biocompatibility that is scientifically valid — not necessarily GLP-wrapped
  • Mechanical and functional bench data
  • Sterilization verification (batch-level / verified sterility is accepted for early feasibility; include packaging-integrity and sterile-barrier evidence)
  • An ISO 14971 risk file
  • An investigator’s brochure that documents all available safety information
  • A written plan for which studies you will later repeat under GLP if the file is going to FDA

For implants, the same guide names endotoxin testing (LAL or rFC; USP <85> / ISO 11737-1). This page still does not prescribe a required n, species, or duration.

FDA later is a different question

Whether a Latin America first-in-human file later supports an FDA IDE, 510(k), De Novo, PMA, or HDE is a 21 CFR § 812.28 question, not the Latin America start gate. The short answer is on does FDA accept LATAM clinical data. The long answer, including the typical testing frame (not a statute) and the ReGelTec package, is the FDA-acceptance FIH guide. ISO 14155 is the device GCP bridge. A Latin America ethics letter is not an FDA clearance prediction.

Build the brochure and the trial master file as if an inspector will ask for them. That is how you keep the Latin America FIH usable later. It is not how Brazil, Panama, or El Salvador decide whether you may start.

Related bioaccess® pages

Official government sources cited

If you are planning a Latin America first-in-human or early-feasibility device study, send bioaccess® the investigator’s brochure and the risk file. We will tell you whether the narrative is complete enough for the ethics committee and, where it applies, the national authority — or where the gaps are — without inventing an animal quota the official texts do not write.

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