Short answer: Most avoidable delays in a first-in-human (FIH) device study in Latin America come from treating the region like a US study with a Spanish consent form. The ten mistakes below are the ones that most often send a dossier back or hold a shipment: planning the US Food and Drug Administration (FDA) use of the data too late, assuming every country follows the same sequence, incomplete or untranslated dossiers, missing manufacturing and sterility evidence, chasing marketing documents the trial does not need, leaving import to the end, insurance that does not match local rules, paying participants the US way, underestimating amendments, and forgetting post-trial obligations. Each one has a primary source and a deeper guide on this blog.
As one founder put it, it would be a pity to be delayed by something nobody told them to prepare. This list is meant to be that warning. It is general; the exact requirement in each country should be confirmed for each study.
1. Planning the FDA use of the data after the study
If the FIH data will support an investigational device exemption (IDE) or a US marketing submission, FDA’s rule for foreign data applies from day one. Under 21 CFR 812.28 (Code of Federal Regulations, CFR), FDA accepts data from a study outside the United States if it is well designed and well conducted and the sponsor provides a statement that it followed good clinical practice (GCP), which includes independent ethics committee review before the study starts and documented informed consent. FDA must also be able to validate the data “through an onsite inspection, or through other appropriate means, if the agency deems it necessary.” Retrofitting that file after the last participant is much harder than building it as you go.
Go deeper: 21 CFR 812.28 inspectability · Building an inspectable ISO 14155 file · FDA acceptance of Latin American data · What to send in a Q-Submission
2. Assuming every country runs the same sequence
The order of approvals differs. In Costa Rica, the institution or investigator submits the study to a scientific ethics committee (CEC, comité ético científico) of its choice before any interventional research starts (Reglamento 39061-S as amended by DE 44033-S, Art. 44). In Panama, a protocol run at an institution first needs a no-objection note from the institution (Decreto Ejecutivo 21 of 2026, Art. 47), and import of investigational products depends on registration of the project in the RESEGIS platform, ethics approval and authorization by the National Directorate of Pharmacy and Drugs (DNFD, Dirección Nacional de Farmacia y Drogas) (Art. 99). In El Salvador the Superintendencia de Regulación Sanitaria (SRS) authorizes the trial (SRS authorization guide). In Chile, device trials need special authorization from the Instituto de Salud Pública (ISP) (Código Sanitario, Art. 111 A). Build the calendar country by country, not from a template.
Go deeper: Rapid startup archetypes by country · Chile vs Panama decision framework · Costa Rica activation calendar · FIH device trials in Chile
3. Submitting an incomplete or untranslated dossier
Ethics committees review what is in front of them, and a missing item usually means another review cycle. Costa Rica’s list for interventional studies is long and specific. It includes the protocol in its original language with an official Spanish translation, the consent form in plain Spanish with date and version, and each team member’s CV, license and a recent GCP course certificate endorsed by the National Health Research Council (CONIS, Consejo Nacional de Investigación en Salud) (Art. 44(b), (d) and (z)). Panama’s institutional no-objection note is a prerequisite for ethics review, not an afterthought (Art. 47). Work from each country’s checklist and translate early.
Go deeper: Latin America FIH submission package checklist · Qualifying sites and investigators
4. Arriving without manufacturing and sterility evidence
Startups often have a prototype line, not a certified plant, and assume that is a problem only for later. It comes up at the first review. Costa Rica asks for evidence that the device was made under good manufacturing practice (GMP), and sterile devices also need a sterility certification (Art. 44(r)). El Salvador’s device requirements include a GMP certificate or a declaration of conformity from the manufacturer, safety and performance test evidence, a description of the manufacturing process and a sterility certificate describing the method, validation and final verification (SRS guide, section 7.2). Assemble this package before you choose a submission date.
Go deeper: GMP attestation vs ISO 13485 certificate · GLP, GMP and sterility requirements · Preclinical testing before FIH
5. Chasing marketing documents the trial does not need
An investigational device is, by definition, not yet on the market, and trial dossiers are built around that. Costa Rica, for example, asks for registration certificates for the device only “si ya se encuentran registrados” (Art. 44(j)). Teams sometimes lose time trying to obtain commercial documents, such as a certificate of free sale, that belong to market registration rather than to the clinical trial pathway. Check which documents the trial route actually asks for before requesting anything from a manufacturer or a foreign authority.
Go deeper: The certificate of free sale trap
6. Leaving import and the importer of record to the end
The device has to reach the site legally, and that has its own approvals. Panama ties import to RESEGIS registration, ethics approval and DNFD authorization (Art. 99). El Salvador’s application lists the establishments associated with the research center, “incluido el establecimiento importador” (SRS guide, section 6.1.1.5). Decide early who the importer of record is in each country, and plan shipping, customs, storage conditions and returns as part of the startup calendar, not after approval.
Go deeper: Investigational device import calendar · Importing investigational devices · Importer of record for trial devices · Multi-country importer of record playbook
7. Buying insurance that does not match local rules
A global policy is not automatically acceptable locally. Costa Rica asks for the sponsor’s commitment to compensate participants for study-related injury “con copia de la póliza vigente por al menos dos años después de finalizado el estudio”, and for insurance covering the investigator and team for claims arising from the study (Art. 44(jj) and (kk)). In Chile, once harm is proven, the law presumes it arose from the research (Código Sanitario, Art. 111 E). Check the policy’s territory, named insureds, duration and certificate wording against each country’s requirements before you submit.
Go deeper: Clinical trial insurance in Latin America · Buying trial liability before the first site · Site insurance vs sponsor policy · Panama FIH insurance · Subject injury vs third-party liability
8. Paying participants the US way
US-style stipends do not travel well. Costa Rica’s Ley 9234 says participants are not paid and only expenses may be reimbursed, with an exception for bioequivalence studies (Ley 9234, Art. 5). Panama allows FIH participants to receive compensation in proportion to time, effort and discomfort, with prior bioethics committee approval (DE 21 of 2026, Art. 62). A compensation plan copied from a US budget can trigger a rejection or a consent rewrite. Set it country by country.
Go deeper: Healthy volunteers in Phase 1 studies in Latin America
9. Underestimating protocol amendments
Every substantive change goes back through review. Chile’s device guide says the principal investigator must obtain written, dated ethics committee approval before enrolling and before implementing later modifications, where requested (ISP / ANDIM guide, section 10.4(c)). (ANDIM is the ISP’s Agencia Nacional de Dispositivos Médicos department.) Each amendment also has to be reflected in translations, consent versions and, sometimes, the import file. Freeze the protocol as far as you can before submission and group unavoidable changes.
Go deeper: Ethics committee amendment cycles · Protocol amendments and regulatory rework
10. Forgetting post-trial obligations
What happens after the last visit is part of the approval. Chile gives the trial participant the right to continued treatment at no cost “por todo el tiempo que persista su utilidad terapéutica, conforme al protocolo de investigación respectivo” (Código Sanitario, Art. 111 C). Costa Rica’s dossier includes the sponsor’s commitment to provide the study device free of charge if it has proven beneficial to the participant’s health (Art. 44(ll)). Decide your post-trial position before submission and write it into the protocol and consent.
Go deeper: Compassionate use vs post-trial access
One more: decide the product category first
Borderline products such as drug-coated devices or skin-contact patches can be combination products under 21 CFR 3.2(e) or can sit near the cosmetic line. If the category is wrong, the whole dossier is wrong. Settle it with the regulators before writing the protocol.
Go deeper: Combination products tutorial · FIH quote checklist for sponsors
Where bioaccess® fits
bioaccess® runs first-in-human and early feasibility medical device studies in Latin America. Most of what we do before a study starts is catching the items on this list early: building the country sequence, assembling the dossier and manufacturing evidence, lining up import and insurance, and setting participant compensation and post-trial terms that each committee will accept.
Related reading
FAQ
What is the most common avoidable delay in a Latin American FIH device study?
An incomplete dossier. Ethics committees and health authorities review what is submitted, and a missing translation, certificate or commitment usually means another review cycle. Working from each country’s own checklist avoids most of it.
Do I need to plan for FDA before the study starts?
Yes, if the data will support a US filing. Under 21 CFR 812.28, FDA accepts foreign device data from well-designed, well-conducted studies that follow good clinical practice, including ethics committee review and informed consent, and FDA must be able to validate the data, for example by inspection.
Is the approval sequence the same in every Latin American country?
No. Costa Rica starts with a scientific ethics committee, Panama requires an institutional no-objection note before ethics review and links import to RESEGIS registration, ethics approval and DNFD authorization, El Salvador’s SRS authorizes trials, and Chile requires ISP special authorization for device trials.
Does a startup need GMP certification before a first-in-human study?
Not always a certificate, but it needs manufacturing evidence. Costa Rica asks for evidence of manufacture under good manufacturing practice and a sterility certification for sterile devices, and El Salvador accepts a GMP certificate or a manufacturer’s declaration of conformity together with sterility and test evidence.
Can I pay participants in Latin America the way I would in the US?
Not everywhere. Costa Rica’s law allows reimbursement of expenses but not payment, except for bioequivalence studies. Panama allows proportional compensation for first-in-human participants with bioethics committee approval. Set the plan country by country.
What post-trial obligations should a sponsor plan for?
In Chile, trial participants have a legal right to continued treatment at no cost while it remains therapeutically useful, according to the protocol. In Costa Rica, the sponsor commits to provide the study device free of charge if it has proven beneficial. Decide your position before submission.