Pre-Study Document Checklist by Country for Medical Device First-in-Human Studies in Latin America

Short answer: Before a medical device first-in-human (FIH) study can start in Latin America, three gates have to be cleared: the ethics committee, the health authority and, for imported devices, the import or customs-release step. The core dossier is largely the same in every country. The differences are in translations, who files, which quality documents are accepted and what each committee adds on top. This checklist sets out what the regulations of Costa Rica, Panama, El Salvador, Chile and Peru say, with the primary source next to each item. Anything we could not verify in a primary text is marked “confirm per study”.

bioaccess® is a contract research organization (CRO) that runs FIH and early feasibility medical device studies in Latin America. Sponsors, especially medtech startups, often ask us for one list they can work from before the protocol is final. This is that list, written for device studies in general. It is not legal advice, and committees can ask for more than the regulation lists.

How to read this checklist

• Ethics committee (EC): reviews the protocol, consent and investigator documents. The local names differ: Comité Ético Científico (CEC) in Costa Rica and Chile, Comité de Bioética de la Investigación (CBI) in Panama, and Comité Institucional de Ética en Investigación (CIEI) in Peru.
• Health authority: registers or authorizes the study and, in some countries, evaluates the investigational device.
• Import: clears each shipment of an unregistered investigational device. A document accepted at one gate does not automatically satisfy the next.
• “Confirm per study”: the item depends on the device, its classification, the committee or a rule we could not open in a primary source.

The core dossier: documents the sponsor prepares once

These items appear in the requirement lists of several countries. Prepare them once, then adapt them to each country’s format and language.

Sources: Costa Rica, Decreto Ejecutivo 44033-S amending Reglamento 39061-S (Alcance 111, La Gaceta 106, 14 June 2023). El Salvador, SRS clinical-trial authorization guide. Panama, Decreto Ejecutivo 21 of 23 April 2026. Chile, ISP Resolución Exenta 2.050 of 2026 and the Código Sanitario. Peru, Decreto Supremo (DS) 021-2017-SA.

Language, legalization and representation

• Costa Rica: the protocol and IB go in the original language plus an official Spanish translation (Art. 44(b)–(c)).
• El Salvador: all documents filed with the SRS must be in Spanish (SRS guide §5, item 6). The application form names the sponsor’s representative or attorney in El Salvador (§6.1.1.2).
• Panama: documents filed for registration on the Registro y Seguimiento de la Investigación para la Salud (RESEGIS) platform must be in Spanish and match the versions sent to the ethics committee (DE 21 Art. 85).
• Chile: the ISP guide tells a sponsor that does not reside in Chile to select a local representative who acts as the sponsor (ISP guide §9.2.1(b)). The consent must be in non-technical Spanish or the participant’s native language (§5.8.2(d)).
• Peru: the protocol and IB go in Spanish and the original language (Art. 67(l), (n)). A foreign sponsor files its delegation to a local representative with a Hague apostille (Art. 67(f)).
• Apostille or legalization of other foreign documents: Confirm per study and per document.

Costa Rica: CEC, national research council and customs release

Biomedical research is governed by Ley 9234 (La Gaceta 79, 25 April 2014) and its regulation, Decreto Ejecutivo 39061-S, as amended in 2023. The institution or investigator files the package with a CEC of their choice (Art. 44). The Consejo Nacional de Investigación en Salud (CONIS) accredits CECs, CROs and investigators (Ley 9234 Art. 43(b)–(c)).

CEC package (Art. 44), beyond the core dossier

• Investigator’s cover letter requesting review (a)
• Device classification under Costa Rica’s medical device regulation (i)
• List of countries and sites, and expected participants per site and in Costa Rica (k), (o)
• Description of the site, facilities and laboratories (p), plus valid habilitation certificates (dd)
• History of submissions to other Costa Rican CECs (q)
• Team CVs with identity document, current professional license or college registration, and a GCP course certificate under three years old endorsed by CONIS (z)
• Copy of CONIS accreditation of investigators and sub-investigators (aa), team compliance commitment (bb) and conflict-of-interest declarations (cc)
• Injury treatment and indemnity plans (ee); principal investigator (PI) commitments on serious adverse event reporting within 24 hours and periodic reports (ff)–(hh)
• Sponsor commitments: injury costs (ii), insurance for the investigator and team with a copy of the policy (jj), participant compensation with a policy valid at least two years after the study ends (kk), post-study treatment where beneficial (ll), reporting results (mm) and publication role (nn)
• Recruitment plan (oo), emergency plan (pp), signature log (qq) and participant-rights procedure (rr)
• Sworn declaration on whether a CRO (organización de investigación por contrato, OIC) or site management organization (organización de administración por contrato, OAC) takes part, with their CONIS accreditations (ss)
• Technical and medical specifications, inserts and user manuals (tt); sponsor commitment to bear all device-related costs (uu); care and monitoring plan for implantable devices (vv)

Device protocols must also cover items including the device type and regulatory class, novelty, nature and period of exposure, materials, inherent risks, the impact of device failure, expected service life and alternatives (Art. 73). Under Art. 72(c), the PI must be a professional suited to the product under investigation.

Ley 9234 Art. 31 requires a civil-liability policy that covers participants from the start of the study until at least two years after their participation ends, and that is enforceable in Costa Rica. The CEC decides within one calendar month (Art. 42). Whether a given FIH device study must go to a particular committee: Confirm per study.

Import and customs release (Art. 55)

• Import only after CEC approval and registration with CONIS (Art. 55(a))
• Before the first shipment, a CEC-endorsed request to CONIS listing the devices and supplies and their quantities (Art. 55(b))
• For each customs release: CONIS request form, CEC approval letter, commercial invoice or acquisition document, transport document, and a GMP certificate for each manufacturing establishment issued by the authority of the manufacturing country (Art. 55(g)(i)–(vi))

Fees and the current CONIS forms: Confirm per study. For sequencing, see our Costa Rica FIH activation calendar.

Panama: registration, ethics review and product evaluation

Decreto Ejecutivo 21 of 2026 regulates health research under Ley 84 of 2019. Every health research study must be registered with the Ministerio de Salud (MINSA) through the RESEGIS platform before the ethics committee certifies its decision (Arts. 79 and 82).

RESEGIS registration (Art. 84)

• No-objection or consent from the public or private entity where the study will run
• Registration request by the PI from an activated RESEGIS user account
• Protocol and annexes, in the same version that goes to the CBI or the national committee (Comité Nacional de Bioética de la Investigación, CNBI)

MINSA issues a registration receipt for the ethics review within three business days (Art. 86).

Ethics and investigator items

• At least one PI resident in Panama; the committees check this from the time of submission (Art. 69)
• The sponsor’s financial provisions for compensating research-related harm, attached to the documents for ethics review (Art. 67(2))
• GCP courses approved by the CNBI, at least every three years, for the investigator and team (Art. 67)
• Committee-specific forms, format and fees: Confirm per study. See our Panama CNBI procedure checklist.

Product evaluation and import

For high-risk research using “medicamentos o productos para la salud humana”, the Dirección Nacional de Farmacia y Drogas (DNFD) evaluates the product before the trial, using the protocol, GMP certificates or a qualified-person GMP declaration, a certificate of analysis and the IB (Art. 95). Import of research products is based on RESEGIS registration, ethics approval and DNFD authorization (Art. 99). The document list in Art. 95 names the investigational medicamento. How Arts. 88, 95 and 99 apply to an investigational device: Confirm per study.

El Salvador: SRS and the national ethics committee

The Superintendencia de Regulación Sanitaria (SRS) authorizes clinical trials of drugs and medical devices. Its guide applies ISO 14155 (clinical investigation of medical devices, good clinical practice) to device trials (SRS guide §5, item 6). The ethics approval minutes are one of the SRS requirements, so ethics review comes first (§6.4(1)).

SRS general requirements (§6.4), beyond the core dossier

• Authorization from the head of the public institution where the trial runs, if applicable (5)
• PI declaration of compliance with GCP, the Declaration of Helsinki and current rules (6); same declaration from sub-investigators and staff (8)
• Joint sponsor–PI declaration of economic capacity to finish the trial (7)
• Training certificate for staff who handle, store or dispense the investigational product, when they are outside the pharmacy or biomedical area (11)
• Contract between the research center and any associated centers (13)
• Insurance policy that applies in El Salvador (14)
• Appointment of the data safety monitoring committee and the schedule for its safety reports (15)
• Fee receipt (18). Amount: Confirm per study

The application form also asks for the PI’s current workload and the research center’s SRS establishment registration number (§6.1.1). The device-specific list in §7.2 is covered in the core dossier above.

The ethics committee’s own document list (Comité Nacional de Ética de la Investigación en Salud, CNEIS) and the import permit steps: Confirm per study. We did not open the current CNEIS manual for this guide.

Chile: CEC, site director and ISP

Under Ley 20.120 Art. 10, biomedical research needs the express authorization of the director of the establishment, after a favorable report from the CEC (Ley 20.120). Under Código Sanitario Art. 111 A, any device that is not registered, or is used differently from its registration, needs an ISP special authorization for provisional use for research. The filing comes after approval under Ley 20.120 Art. 10 and includes the protocol, the consent form, the insurance policy and any other document set by regulation. The authorization lasts up to one year and can be renewed. The Ministry of Health may exempt low-risk devices by decree. Whether any such exemption covers your device: Confirm per study.

CEC initial submission (ISP guide §5.6.2)

The ISP device guide approved by Resolución Exenta 2.050 of 2026 recommends, as a minimum: the protocol, the IB or equivalent, the consent form and other written participant information, recruitment procedures and materials, and the PI’s CV. Depending on the design and the committee, it may also be necessary to file the CRF, documents on payments and compensation to participants, the clinical investigation agreement and site payment, conflict-of-interest documents, evidence of insurance, the sponsor’s delegation of duties, and the CVs of other team members.

Other Chile items

• Local representative for a sponsor that does not reside in Chile (ISP guide §9.2.1(b))
• Civil-liability insurance held by the authorization holder (Código Sanitario Art. 111 F). The same article says a decree sets the device classes for which an insurance policy is mandatory. How that applies to your device: Confirm per study.
• Research centers must be accredited by the ISP under Art. 111 D. How this applies to your site today: Confirm per study.
• The ISP dossier list for the device provisional-use authorization: Confirm per study. ISP ran a public consultation on its filing guide in June and July 2026, and we have not confirmed the final version.

Related: Chile ISP clinical trial approval for medical devices and Chile ISP device vs drug trials.

Peru: CIEI approval and national authorization

DS 021-2017-SA sets the documents the sponsor or CRO files with the Instituto Nacional de Salud (INS) to authorize a trial (Art. 67). Beyond the core dossier, the list includes the registration of each research center, approval from the institution’s legal representative, CIEI approval of the protocol and consent, sworn declarations from the sponsor and the PI, a declaration on site conditioning, a sworn declaration of a fund for immediate care of participants until the insurance activates, a supply list and the fee receipt. Training in GCP and research ethics must be no more than three years old (Art. 67(q)).

Art. 68 limits authorization to investigational products that meet one of several conditions, such as authorization for human research by a regulator from a high-surveillance country. How Art. 68 applies to a device that has never been used in people, and whether later amendments change Art. 67: Confirm per study.

Items to confirm per study

• Device classification in each country, which drives several requirements (Costa Rica Art. 44(i))
• Panama: how DE 21 Arts. 88, 95 and 99 apply to investigational devices, and which committee reviews the study
• Chile: the ISP provisional-use dossier list, any exemption decree, and site accreditation under Art. 111 D
• El Salvador: the CNEIS document list and the import permit steps
• Peru: how Art. 68 applies to an FIH device, and any amendments to DS 021-2017-SA
• Apostille or legalization of each foreign document
• Committee forms and fees in every country
• What replaces a prior-agency approval letter when the device has none (Costa Rica Art. 44(h); El Salvador §6.4(17))

A practical order of work

1. Freeze the protocol version you will translate. Every country ties its filings to a dated version.
2. Build the device technical file to the El Salvador §7.2 list. It is the most detailed device list among the texts reviewed here.
3. Collect investigator CVs, licenses and GCP certificates early, and check their dates against the three-year limits in Costa Rica, Panama and Peru.
4. Line up the insurance policy for each country before submission. See our clinical trial insurance guide.
5. Plan the import-stage documents before ethics approval, not after. See importing investigational devices into Latin America.

Related reading: The universal Latin America FIH submission package · GMP attestation or ISO 13485 certificate? · How we qualify FIH sites and investigators · Protocol template for FIH devices

Frequently asked questions (FAQ)

What documents does every Latin American ethics committee ask for in a device first-in-human study?

In the texts reviewed for Costa Rica, El Salvador, Chile and Peru, the common items are the protocol, the investigator’s brochure, the informed consent form, investigator CVs and an insurance policy. Costa Rica, El Salvador and Peru also require GCP training evidence. Panama’s ethics committees apply their own document lists, so confirm those per study.

Do I need a GMP certificate or is a manufacturer declaration enough?

It depends on the country and the filing stage. Costa Rica accepts a manufacturer GMP statement at the ethics committee but asks for an authority-issued GMP certificate for customs release. El Salvador accepts a GMP certificate or a manufacturer declaration of conformity for devices. For other countries, confirm per study.

Does a device first-in-human study in Chile need ISP authorization?

Código Sanitario Article 111 A requires an ISP special authorization for provisional use for any device that is not registered or is used differently from its registration, after ethics approval. The Ministry of Health may exempt low-risk devices by decree, so confirm per study whether an exemption applies.

Must the investigators’ GCP training be recent?

Yes in several countries. Costa Rica asks for a CONIS-endorsed GCP course under three years old. Panama requires GCP courses approved by the national bioethics committee at least every three years. Peru asks for GCP and research ethics training no more than three years old.

Must documents be in Spanish?

Costa Rica requires an official Spanish translation of the protocol and investigator’s brochure. El Salvador requires all SRS filings in Spanish. Panama requires RESEGIS filings in Spanish. Peru asks for the protocol and brochure in Spanish and the original language. Chile requires the consent in Spanish or the participant’s native language.