General information, not legal or insurance advice. Rules change. Confirm the current requirement with the reviewing ethics committee, the health authority and a broker licensed in each country before you rely on it. bioaccess® is a CRO. We don’t sell, underwrite or bind insurance.
If you’re a US or other foreign sponsor planning a study in Latin America, insurance will come up early. It also tends to come up in the wrong order. Sponsors often try to buy a policy before they have a protocol, or assume the US product-liability policy they already hold will satisfy an ethics committee in Lima or San José.
This guide covers what the law actually says in the main Latin American markets. For each country we answer five questions: is insurance mandatory, which rule requires it, does the policy have to sit with a local insurer, what term or minimum applies, and when in the submission you need it. Every cell in the comparison table cites the rule it comes from, with a link to the official text. Where a law is silent on a point, we say the law is silent rather than guess.
Key takeaways
- Most of the region requires it, but not in the same way. Peru, Costa Rica, Argentina (drug trials), Chile, Guatemala and Mexico have written requirements. Colombia, the Dominican Republic and El Salvador put the policy on the ethics or submission checklist. Brazil’s 2024 law imposes an indemnity duty on the sponsor but doesn’t require a policy in the statute. Panama’s 2026 decree requires financial provisions for compensation.
- “Local” matters. Argentina requires a policy “constituted in the country”. Peru requires coverage in Peru, and a foreign insurer must have a legal representative there. Costa Rica requires a policy that is “valid and enforceable” in Costa Rica from an insurer with a branch or service center in the country. Separately, the general insurance laws of Mexico, Brazil, Chile, Colombia, Panama and the Dominican Republic limit cover bought from insurers that aren’t authorized in the country; how far those limits reach a trial policy bought abroad is a question for a local broker. A worldwide master certificate on its own often won’t satisfy the reviewer.
- The policy follows the protocol, not the other way around. Insurers price a specific study: its design, risk, number of participants, countries, sites and duration. In Mexico (per NIH ClinRegs) and at some Chilean ethics committees, the policy must identify the study. Without a protocol there’s nothing to underwrite.
- Tail periods are written into statute or regulation in some countries. Costa Rica requires cover for at least two years after the final report is delivered to the ethics committee, and three years after each participant’s participation ends. Peru requires the policy to run until the National Final Report and to be renewed while late damages are possible.
- Mexico changed the sequence in 2025. COFEPRIS now authorizes the protocol first. The sponsor then has 15 business days to file the policy or a financial fund, or the authorization can be revoked. That changed only the COFEPRIS filing: ethics committees may still ask to see the policy before they approve.
Why Latin American rules differ from what US sponsors expect
In the United States no federal rule requires clinical trial insurance. Coverage is usually driven by site and CRO contracts. Much of Latin America works differently: participant-injury protection is written into health regulation, ethics committees check the policy as part of approval, and several countries’ general insurance laws limit cover placed with insurers that aren’t authorized locally.
There’s also a liability point. Several countries make the sponsor responsible for trial-related injury whether or not anyone was at fault, and regardless of what the policy pays:
- Chile: the holder of the investigational-use authorization is liable even for damage that couldn’t have been foreseen. Once damage is shown, causation by the trial is presumed, and the limitation period is ten years from when the damage appears (Código Sanitario art. 111 E).
- Guatemala: if the policy doesn’t cover the full damage, the sponsor is liable for the rest without any need to show fault (Acuerdo Ministerial 82-2019, §11.4).
- Peru: the sponsor’s duty to compensate is independent of the policy’s validity or limits (DS 021-2017-SA, art. 29).
So the policy is how the sponsor proves it can pay for that duty. It doesn’t replace the duty.
Country comparison table
| Country |
Insurance mandatory? |
Legal basis |
Local insurer or local policy? |
Term or minimum in the rule |
When it’s needed |
| Brazil |
Sponsor must indemnify; the statute has no insurance mandate |
Lei 14.874/2024, arts. 23, 26 XV |
Yes for Brazil-domiciled buyers: cover for risks in Brazil must be placed in Brazil, with narrow exceptions (Lei Complementar 126/2007, arts. 19–20) |
None in the statute |
Not fixed by the statute. CEP/Conep ethics review doesn’t ask for proof of insurance (CONEP manual, 2015), so any timing comes from site contracts |
| Mexico |
Yes: insurance or a financial fund |
COFEPRIS Acuerdo of 24 Apr 2025, art. 5; NOM-012-SSA3-2012 §5.14 |
Yes: liability cover for events that can occur in Mexico may not be bought from a foreign insurer unless the CNSF grants an exception (Ley de Instituciones de Seguros y de Fianzas, arts. 21 IV, 22, 24) |
None in the rule |
COFEPRIS: within 15 business days after protocol authorization. Ethics committees may ask for it before they approve |
| Colombia |
On the GCP ethics and sponsor checklists (drugs); INVIMA also checks for a policy in device studies |
Res. 2378/2008, Technical Annex; Res. 8430/1993, art. 13; INVIMA device-study inspection tool |
No trial-specific rule. Foreign insurers may not sell cover in Colombia; residents may buy abroad except mandatory insurance (EOSF art. 39, as amended by Ley 1328/2009, art. 61) |
Value “according to international standards” (Res. 2378); no amount or term |
In the ethics file before approval |
| Argentina |
Yes for national drug trials for registration. Buenos Aires City requires insurance or another financial guarantee for research there; Buenos Aires Province requires the health institution to show insurance before a higher-risk protocol is approved |
ANMAT Disp. 7516/2025, Annex II §3.14; CABA Ley 3301, art. 12; Buenos Aires Province Decreto 3389/2024, art. 8 |
Yes (drug trials): “seguro constituido en el país”. Buenos Aires Province: insurer recognized by the national insurance regulator (SSN) |
No national minimum. Buenos Aires Province: at least 1 year after the study ends. Buenos Aires City: through the civil-code limitation period |
Before the study starts; insurer named in the consent form |
| Chile |
Yes, for drugs; for devices, in the classes a decree is to set (not yet issued) |
Código Sanitario arts. 111 A and 111 F; DS 114/2010, art. 25 (as amended by DS 30/2012) |
On our reading, art. 111 F makes this a legally required insurance, which would bring it within DFL 251, art. 4 (insurers established in Chile). We found no CMF or ISP ruling, and Hospital Clínico U. de Chile asks industry sponsors to name their representative in Chile rather than a Chilean insurer. Confirm with a Chilean broker |
None in the statute. Claims can be brought for 10 years (art. 111 E). CEC Salud UC requires cover through formal closure |
Filed with the ISP authorization request, after ethics approval (art. 111 A) |
| Peru |
Yes, plus a financial fund |
DS 021-2017-SA, art. 28 |
Coverage in Peru; foreign insurer needs a legal representative in Peru |
Until the National Final Report, then renewed while late damage is possible |
Before authorization; details in the consent form |
| Costa Rica |
Yes |
Ley 9234, art. 31; Reglamento 39061-S, art. 14 |
Enforceable in Costa Rica; insurer with a branch or service center in the country |
Decreto 39061-S art. 14: at least 2 years after the final report is delivered to the CEC, and 3 years after each participant’s participation ends. Ley 9234 art. 31 floor: 2 years after participation ends |
Ethics review before start; each participant gets proof of the policy |
| Panama |
Sponsor “financial provisions” required |
Decreto Ejecutivo 21/2026, art. 67(2) |
On our reading, yes for Panama-domiciled buyers: insurance on people and property in Panama must come from locally authorized insurers, unless the cover isn’t available or is declined locally (Ley 12 de 2012, art. 153) |
None in the decree |
Attached to the bioethics submission |
| Dominican Republic |
Yes (submission requirement) |
CONABIOS requirements (2025) and Manual (12 July 2022) |
Insurance on people’s life and health must be written in the country by locally authorized insurers; surplus lines are exempt (Ley 146-02, art. 6). Art. 6 lists life, health and property; whether it reaches a trial-liability policy is a question for a local broker |
None in the CONABIOS rules |
At submission to CONABIOS |
| Guatemala |
Yes (drug and device trials) |
Acuerdo Ministerial 82-2019, §§2, 11, 41, 43.8 |
Insurer established in the country or working with a national insurer (§11.3) |
Payouts must equal what the sponsor would pay for the same damage in the trial’s country of origin (§11.3) |
Before the trial starts |
| El Salvador |
Yes, as a CNEIS submission and SRS inspection requirement |
CNEIS SOP manual (2018); SRS GCP inspection guide (2025) |
Policy must show how it applies in El Salvador |
None in the CNEIS or SRS documents |
With the CNEIS submission; checked at inspection |
How to read the “local insurer” column: where a clinical-trial rule is silent, we cite the country’s general insurance law. Brazil’s, Colombia’s and Panama’s rules bind buyers who are resident or domiciled in the country; Mexico’s is framed by where the event can occur. How these rules apply when a foreign sponsor buys cover abroad is a structuring question for a broker licensed in that country. Every cell was checked against the linked text on 29 October 2026. Where a cell says “on our reading”, it is our interpretation of the text, not an official ruling.
None of the rules above sets a minimum dollar limit. Limits come from site and CRO contracts and the insurer’s underwriting. None of the ethics-committee rules we read sets a minimum either.
Country by country
Brazil
Legal basis: Lei 14.874/2024, the national law on research with human beings. Art. 23 says participants will be indemnified for damage arising from their participation and will receive related health care, and that the sponsor is responsible for both. Art. 26 XV repeats this among the sponsor’s duties. Art. 26 §3 makes the participating institutions jointly responsible for full care of participants. Art. 18 §3 bars any consent-form language suggesting the participant waives rights or that the sponsor is exempt from liability. Lei 14.874 is regulated by Decreto 12.651 of 7 October 2025, which covers the national ethics system, CEP accreditation, risk classification and post-study access; we found no insurance requirement in it.
Is a policy mandatory? The statute doesn’t require an insurance policy. It requires the sponsor to pay. Ethics review doesn’t add a policy requirement either (see CONEP’s guidance below). If a policy is bought, Brazil’s insurance law shapes where it is placed. Under Lei Complementar 126/2007, art. 19, insurance bought by people resident in Brazil or companies domiciled there to cover risks in Brazil must be placed in Brazil. Art. 20 allows cover abroad only in narrow cases, such as when no Brazilian insurer offers it. In practice that points to a local policy from an insurer authorized by SUSEP, the federal insurance regulator, when a Brazil-domiciled party buys the cover. Whether it reaches a foreign sponsor buying abroad is a question for a SUSEP-registered broker.
Ethics-committee practice (CONEP guidance, not law): CONEP, which runs Brazil’s national ethics-review system, says in its Manual de orientação: pendências frequentes em protocolos de pesquisa clínica (version 1.0, 2015) that “O Sistema CEP/Conep não solicita a comprovação da existência de seguro para execução da pesquisa”. It treats indemnity as the duty of the sponsor, investigator and institution whether or not a policy exists. It says indemnity can’t be limited to the amount insured, and that the consent form must not tie the right to indemnity to a policy the sponsor has bought. The manual was issued in 2015 under CNS Resolution 466/2012, before Lei 14.874/2024 and Decreto 12.651/2025. Art. 39 of the decree keeps CNS ethics norms in force, where they don’t conflict with the law or the decree, until the new national ethics body issues its own. We found nothing newer that changes CONEP’s position.
For device sponsors: the law applies to medical devices “no que couber” (where applicable) (art. 62). ANVISA’s device-trial rule is RDC 837/2023.
Mexico
Deep dive: Mexico’s 15-business-day insurance rule.
Legal basis:
- NOM-012-SSA3-2012 §5.14: the research budget must include a financial fund and mechanisms to guarantee continued treatment and the compensation a participant is legally owed for directly related damage. That fund “may be covered with the study insurance”.
- §7.2: the institution, the committees, the PI and, where applicable, the sponsor are responsible for health damage caused by the research.
- §10.6: the consent form must state the participant’s right to compensation and to free treatment.
What changed in 2025: COFEPRIS’s simplification Acuerdo (signed 24 April 2025, published in the DOF on 28 April 2025) removed the study insurance from the initial protocol application. Article 5 now requires the applicant to file three things within 15 business days after the protocol is authorized:
- the ethics-approved consent form
- the “Seguro del estudio (Póliza/Certificado) o fondo financiero vigente” that covers the participants
- the emergency-care form and agreement
Authorizations without this complete information may be revoked. No-risk observational studies are exempt from the insurance and emergency-care items. The sponsor also signs a sworn statement in the new single sponsor form (Formato Único del Patrocinador) committing to file these documents. Changing sponsor (amendment J) requires the policy or fund again.
Policy content: according to ClinRegs, earlier COFEPRIS guidance said the policy or certificate must be in the name of the license holder and the sponsor, cover all local participants, and show the number of participants, the study title and the protocol number.
Local insurer: the COFEPRIS rules don’t address it, but Mexico’s insurance law does. Ley de Instituciones de Seguros y de Fianzas art. 21 prohibits buying from foreign insurers both liability insurance for events that can occur in Mexico (fraction IV) and insurance of persons where a company buys it for people resident in Mexico (fraction I(b)). The CNSF can grant an exception when no authorized Mexican insurer can or will write the risk (art. 22 II). Contracts that breach art. 21 have no legal effect (art. 24). In practice, that points to a policy issued by an insurer authorized in Mexico.
Colombia
Legal basis: Resolución 2378 de 2008 adopts Good Clinical Practice for institutions running research with medicines. Its Technical Annex lists “Póliza de seguro para los participantes” among the documents the ethics committee reviews and files. The sponsor checklist asks whether the sponsor provides a “póliza contractual y extracontractual para eventos adversos asociados y atribuibles al producto de investigación, cuyo valor estará de acuerdo con estándares internacionales”. In plain terms: contractual and non-contractual liability cover for adverse events attributable to the investigational product, sized to international standards.
Who and when: the sponsor, before ethics approval.
Device studies: Res. 2378 is written for medicines. For devices, Resolución 8430 de 1993, art. 13, makes the research institution or sponsor responsible for care of any participant harmed by the research, “sin perjuicio de la indemnización que legalmente le corresponda”. INVIMA’s inspection tool for device clinical research checks that the contract includes a policy, that the policy is in force, and that neither the policy nor the consent form limits the participant’s rights or right to sue.
Local insurer: no clinical-trial rule requires a Colombian insurer. Colombia’s general insurance law (Estatuto Orgánico del Sistema Financiero, art. 39, as amended by Ley 1328 de 2009, art. 61) bars foreign insurers from selling or advertising cover in Colombia, except marine, aviation and goods-in-transit lines. Residents may buy insurance abroad, except mandatory insurance (“seguros obligatorios”) and a few other categories. The Superintendencia Financiera reads that exception to mean that mandatory cover can’t be bought abroad.
Ethics-committee practice (not law): Clínica Universidad de La Sabana’s ethics committee (initial-submission requirements, web page, undated) asks for the “Póliza de seguros que cubre el protocolo”. For multinational policies it also asks for a description of the indemnity and coverage arrangements and of how the policy applies locally. Fundación Valle del Lili’s ethics committee lists the “Póliza de Responsabilidad” among the documents reviewed for new pharmaceutical protocols (Circular No. 01, 2026 fees, 6 January 2026). Neither sets an amount.
Argentina
Legal basis: ANMAT Disposición 7516/2025. It was published on 9 October 2025, took effect on 1 December 2025, and replaced the 6677/2010 regime. Annex II covers local GCP requirements for clinical pharmacology studies for registration:
- §3.14.1: the sponsor must ensure medical care and contract insurance “en el país” for harm the study causes to participants. Approval doesn’t exempt the sponsor from legal liability.
- §3.14.2: a study may only be carried out once the sponsor has contracted a “seguro constituido en el país” to cover the risks or potential damage to participants.
- §1.2.2(t): the study insurance policy is part of the ethics committee file.
- Appendix D (consent form): the consent form must name the insurance company and its address. It may not include limiting phrases such as “damages will be covered if you followed the study doctor’s instructions” or “reasonable costs will be covered”.
Device studies: ANMAT’s device-trial rule, Disposición 969/1997, has no insurance clause. It makes the sponsor bear all study costs (§2.3.6). Local law fills the gap in Argentina’s two largest research hubs:
- City of Buenos Aires: Ley 3301, art. 12, allows research to proceed only once insurance or another financial guarantee is in place, unless the sponsor is a state body. The sponsor buys it. It must cover the sponsor, PI, team and institution, cover direct and indirect damage, and run after the study for the civil-code limitation period. The participant information sheet that goes with the consent form must name the insurer and policy number (art. 10(p)). The authority may grant exemptions from the insurance requirement (art. 5.1.18).
- Buenos Aires Province: Decreto 3389/2024 (regulating Ley 15.462), art. 8, requires the health institution to show a care-and-indemnity insurance before a higher-risk (“riesgo mayor”) protocol is approved, plus professional liability cover for the research team. The insurer must be recognized by the Superintendencia de Seguros de la Nación, and cover must last at least one year after the study ends.
- Córdoba (provincial ethics council rule): the CoEIS, which accredits Córdoba’s institutional research ethics committees under provincial Ley 9694, requires in Disposición CoEIS 44/2023 (28 April 2023), art. 2(e), that pilot studies not intended for national registration present “el Seguro de Responsabilidad Civil para Investigación Clínica según lo establecido en la Disposición CoEIS N°: 37/18”. The rule covers studies of medicines and of “productos médicos” (devices) (art. 3). We could not open Disposición 37/18 itself.
Chile
Legal basis: Código Sanitario art. 111 F, added by Ley 20.850. Holders of the special provisional-use authorization for research with pharmaceuticals or medical devices must hold civil liability insurance, under a Ministry of Health regulation. A supreme decree is to set which classes of medical devices require the policy; it hasn’t been issued. Ley 20.120’s regulation (DS 114/2010, art. 25, as amended by DS 30/2012) also requires every protocol for scientific research in human beings under that law to set out “los resguardos necesarios para precaver mediante los seguros y garantías que procedan” the foreseeable and unforeseeable adverse events, which applies to device studies too. Art. 111 E makes the holder liable even for unforeseeable damage, presumes causation once damage is shown, and sets a ten-year limitation period from when the damage manifests.
What ethics committees ask for: the Health Sciences Ethics Committee of the Pontificia Universidad Católica (CEC Salud UC) issued a statement in March 2025 setting its minimums. The insured must be the authorization holder, the policy must identify the study, it must cover all civil damages related to the research, and it must stay in force until formal closure, including the last follow-up visit.
Ethics-committee practice in Chile (committee rules, not law)
With the art. 111 F regulation still pending, we read the published rules of accredited Chilean scientific ethics committees (CECs) on 29 October 2026. Every committee whose rules we could open asks for the policy as a submission document for clinical trials, and several name device trials expressly. None sets a minimum amount.
- CEC Salud UC (Pontificia Universidad Católica), Declaración sobre pólizas (March 2025): applies to drug, vaccine and medical-device trials. The insured is the authorization holder, the policy names the study and covers all civil damages, and it stays in force through formal closure, including the last follow-up. It must show start and end dates and be current at each annual renewal.
- Universidad de Chile, Faculty of Medicine CEISH, Reglamento approved by Resolución Exenta 697 (30 October 2024): covers trials of “productos farmacéuticos y dispositivos médicos”; for clinical trials it asks for “la póliza y certificado de seguro”, and its review form includes “compensación por daños / seguro de riesgos”. Its submission checklist (v3.6, 19 June 2025) asks for the insurance certificate.
- Hospital Clínico Universidad de Chile, requirements for industry-funded studies (March 2026): for studies sponsored by the pharmaceutical industry, a copy of the policy, “señalar quién es el representante en Chile y su vigencia” (name the Chilean representative and the policy period).
- Clínica Alemana–Universidad del Desarrollo CEC, Reglamento Interno (January 2026): “Póliza de seguros asociados (en caso de ensayos clínicos)” in the submission file; the consent form must state the insurance guarantee for compensation; the committee reviews device and surgical-procedure trials.
- Clínica Las Condes CEI, Reglamento (v3.0, revised January 2026): “Seguros asociados” among required documents (art. 12) and “previsión de compensación por daños” as a review criterion (art. 14). The committee must protect participants “mediante los seguros o garantías suficientes”, citing standard 10 of MINSAL Norma Técnica 0151.
- Hospital del Trabajador CEC, committee web page (undated): for trials “con productos farmacéuticos o implantes”, “Póliza de seguro según normativa del ISP”.
- Universidad Mayor CEC, committee web page (undated; refers to its 2025/2026 forms): “Póliza de Seguros o garantías en idioma español para la realización del ensayo clínico en Chile”. If the policy excludes investigator malpractice, a separate policy covering it is required.
The binding rule and the accreditation standard behind this: the binding source is DS 114/2010, art. 25 (as amended by DS 30/2012), quoted above. MINSAL Norma Técnica 0151 (Resolución Exenta 403, 11 July 2013; copy hosted by the Servicio de Salud Araucanía Norte), standard 10, restates it for committee accreditation: protocols must state how adverse events will be covered “mediante los seguros y garantías que procedan”. NT 0151 was amended by Resolución Exenta 183/2016, which replaced only standard 9.
Where practice goes beyond the statute: committees already ask for a policy in device trials although the decree setting device classes under art. 111 F hasn’t been issued; that practice rests partly on DS 114 art. 25, which applies to all research in human beings under Ley 20.120. CEC Salud UC also sets a term (through formal closure) that the statute doesn’t. Universidad Mayor asks for Spanish-language cover for Chile, and the Hospital Clínico asks industry sponsors to name a Chilean representative. We found no published insurance requirements on the official sites of the Metropolitan health-service committees (SSM Oriente, Norte, Sur, Central) or of Clínica MEDS and Clínica INDISA.
The policy is part of the ISP application: art. 111 A requires the applicant to file the protocol, the consent form and “la póliza de seguros”, after ethics approval, to obtain the ISP’s provisional-use authorization for any unregistered drug or device.
Local insurer: DFL 251 de 1931, art. 4, lets anyone buy insurance abroad except “los seguros obligatorios establecidos por ley”, which may only be bought from companies established in Chile. On our reading, art. 111 F makes this policy a legally required insurance, which would bring it within that exception. We found no CMF or ISP ruling applying art. 4 to research policies, and Hospital Clínico Universidad de Chile asks industry sponsors to name their representative in Chile rather than requiring a Chilean insurer. The opposite reading is also arguable: art. 111 F leaves the policy’s terms to a regulation that hasn’t been issued. Confirm the structure with a Chilean broker.
Regulation still pending: art. 111 F leaves the policy’s conditions to a Ministry of Health regulation and the covered device classes to a supreme decree. We found neither in searches of official Chilean sources on 29 October 2026. Until they are issued, the statute itself (arts. 111 A, 111 E and 111 F), DS 114/2010 art. 25 and the ethics committees’ requirements are what apply.
Peru
Legal basis: DS 021-2017-SA, the Clinical Trials Regulation.
- Art. 27: the PI and sponsor provide free care for trial-related injury, and the sponsor must indemnify.
- Art. 28: the sponsor must contract a policy covering damages to participants. Until the policy pays out, the sponsor must keep a financial fund for immediate free treatment. The policy must have coverage in Peru, and if the insurer is foreign it must have a legal representative in Peru. This information must appear in the consent form. The policy must stay in force until the National Final Report is submitted, and then be renewed while late damage is possible, up to the end of any lawsuit.
- Art. 29: defines what is compensable, including pregnancy-related damage, and says the sponsor’s duty doesn’t depend on the policy.
Art. 67(j)–(k): the authorization application must include a copy of the policy in force and the sponsor’s sworn statement that it holds the financial fund for immediate free care until the policy pays.
Ethics-committee practice (not law): the EsSalud research ethics committee of the Red Asistencial Cusco, in its procedures manual (2024 edition, published by EsSalud’s IETSI), asks clinical-trial submissions for a “copia de la póliza de seguro del patrocinador (copia original y traducida al español certificada por el traductor)”, specifying how it applies in Peru. Its deviation-report form records the policy’s expiry date. It sets no amount.
Costa Rica
Deep dive: Costa Rica insurance under Ley 9234.
Legal basis: Ley 9234, the Biomedical Research Law.
- Art. 31: clinical research must be covered by a civil liability policy, from the start of the research until at least two years after the participant’s participation ends. The policy must be enforceable in Costa Rica, and the scientific ethics committees (CEC) set its term starting from that minimum.
- Art. 32: each participant receives proof or a copy of the policy showing its number, issuer, term, conditions and claim procedure.
Regulation: Decreto 39061-S, art. 14:
- the sponsor’s policy runs from the start of the study until at least two years after the final report is delivered to the CEC
- each participant is covered from the signing of the consent form until three years after their participation ends
- the sponsor must also cover the investigator and team, except for negligence or protocol violations
- the PI must carry their own civil liability policy
- insurers must have branches or service centers in Costa Rica
Under art. 15, insurers must pay within 30 days of receiving complete documentation, and CONIS refers non-compliance to SUGESE, the insurance regulator.
Panama
More on the decree: Panama Decreto 21 of 2026: what sponsors need to know.
Legal basis: Ley 84 de 2019 and Decreto Ejecutivo 21 of 23 April 2026. Art. 61 gives participants the right to the compensation they need for research-related adverse events, “según los estándares del país”. Art. 67(2) requires the investigator to obtain from the sponsor “las previsiones financieras para la compensación efectiva de los posibles daños” and attach that agreement to the CNBI or accredited bioethics committee submission.
Our reading: the decree requires a documented financial provision. We didn’t find an explicit insurance-policy mandate in its text. A certificate of insurance is the usual way to document that provision, and committees may ask for one.
Local insurer: Ley 12 de 2012, art. 153, requires entities and people domiciled in Panama to buy insurance on people and property in Panama from insurers authorized there. The exceptions are treaties, cover that doesn’t exist in Panama, and cover that authorized insurers have declined, in which case the Superintendency can authorize placement abroad.
Dominican Republic
Basis: the submission checklist of CONABIOS, the national bioethics council, lists “Póliza de seguro para participantes“. Its Manual de Normas y Procedimientos Operativos (12 July 2022) describes this as a civil liability, health or research policy for participants, “as the Council considers appropriate”. The Council also checks the insurance or indemnity that covers the sponsor’s and investigator’s liability.
Local insurer: CONABIOS doesn’t address it. Ley 146-02 on insurance and bonds, art. 6, requires insurance on the life and health of persons, and on property located in the country, to be written in the Dominican Republic through insurers authorized there. Surplus lines (“líneas excedentes”) are exempt, as are cases where the rule would conflict with a treaty the Dominican Republic has signed. Art. 6 lists life, health and property; whether it reaches a trial-liability policy is a question for a local broker.
Guatemala
Basis: Acuerdo Ministerial 82-2019 (MSPAS). It applies to “todo ensayo clínico con un dispositivo o una sustancia” in the investigational phase (§2) and regulates “ensayos clínicos con medicamentos y dispositivos médicos” (§41). The device-trial application must include a “copia de la póliza del seguro del ensayo clínico” (§43.8). Its insurance provisions:
- §11.1–11.2: a trial of an investigational product, a new indication, or one without therapeutic interest for the participant may begin only after insurance covering all resulting damage is in place. Every participant must be covered for injury, disability and death.
- §10.2: the policy covers the civil liability of the sponsor, investigators, collaborators and site, and must be documented before the trial starts.
- §11.3: insurers must be recognized nationally or internationally and either established in Guatemala or working with Guatemalan insurers. Payouts must equal what the sponsor would pay in the trial’s country of origin for the same damage.
El Salvador
Basis: the CNEIS submission checklist asks for information on the sponsor’s participant policy, “specifying how it applies in El Salvador”. The trial regulator, the Superintendencia de Regulación Sanitaria (SRS), uses a 2025 GCP inspection guide that checks whether trials hold policies “under current regulation” (item 4.1.8). The CNEIS manual dates from 2018; the guide doesn’t say which regulation it means, and neither document sets a policy term or minimum.
What every LATAM policy needs to show
Across these countries, reviewers check the same handful of things:
- The study: protocol number and title, and in Mexico the number of participants. A policy can’t be issued for a study that hasn’t been defined.
- The insured parties: the sponsor or authorization holder, and often the PI, team and site. Costa Rica and Guatemala write this into the rule.
- Territory and enforceability: in-country coverage (Peru), “constituted in the country” (Argentina), or enforceable with a local service presence (Costa Rica).
- Period: through the final report and beyond (Costa Rica and Peru), and in Chile at least through closure.
- Consent-form alignment: insurer name and policy details in the consent form (Peru, Costa Rica, Argentina). The policy has to exist before the consent form is final.
- No limiting language: Argentina bans specific phrases, and Brazil bars any waiver of rights.
How to sequence insurance with your submission
- Pick the countries first. Local-insurer and term rules differ, and a policy built for one country doesn’t automatically travel.
- Get the protocol to near-final. Insurers underwrite a specific study. Some brokers will quote from a solid draft, but they still need the design, risk level, enrollment, sites and duration. See our companion guide, What insurers need before they’ll quote a clinical trial policy.
- Request quotes for both a master policy and local policies at the same time. Ask the broker to confirm in writing which countries need admitted local paper.
- Draft the consent form injury section with the policy details in hand.
- Bind and issue certificates before the ethics submission in countries that require the policy upfront. In Mexico, have it ready to file within 15 business days of COFEPRIS authorization.
- Diarize the tail. Costa Rica and Peru set minimum periods after the study ends.
Related guides
How bioaccess® helps
We build insurance into the submission plan from the first country decision. We line up the protocol, consent forms and site list the insurer needs, coordinate certificates and named-insured endorsements with your broker, and check the paperwork against each ethics committee’s checklist. We’re not an insurer, and we don’t sell or bind policies.
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FAQ
Is clinical trial insurance legally required in Latin America?
In most of the main markets, yes. It’s required by statute or regulation in Peru, Costa Rica, Argentina (drug trials), Chile, Guatemala and Mexico, where a financial fund is the alternative. Colombia, the Dominican Republic and El Salvador list it in ethics or submission requirements. Brazil requires the sponsor to indemnify but doesn’t require a policy in its 2024 law, and CONEP’s guidance says ethics review doesn’t ask for proof of insurance. Panama requires documented financial provisions.
Can I use my US product liability or global master policy?
Sometimes, as part of the program, but often not by itself. Argentina requires insurance constituted in Argentina. Peru requires coverage in Peru with a local legal representative for foreign insurers. Costa Rica requires a policy enforceable in Costa Rica from an insurer with a local service presence. Mexico’s insurance law bars foreign insurers from writing liability cover for events in Mexico, and Brazil, Chile, Colombia, Panama and the Dominican Republic have their own limits on cover from insurers that aren’t authorized locally.
Can I get a quote before I have a protocol?
Not a meaningful one. Insurers price the specific study: its design, risk, enrollment, countries, sites and duration. In Mexico (per NIH ClinRegs) and at some Chilean ethics committees, the policy must identify the study. A near-final draft is the practical minimum.
Is there a minimum coverage amount?
None of the national rules we reviewed sets a dollar minimum. Colombia’s GCP resolution refers to “international standards”, and Guatemala requires payouts equal to what the sponsor would pay for the same damage in the trial’s country of origin. None of the ethics-committee rules we read in Chile, Colombia, Peru, Brazil or Córdoba sets one either. Limits are set by contracts and underwriting.
How long must the policy last?
It depends on the country. In Costa Rica, under Decreto 39061-S art. 14, at least two years after the final report is delivered to the CEC, and three years after each participant’s participation ends; Ley 9234 art. 31 sets a floor of two years after participation ends. In Peru, until the National Final Report and longer while late damage is possible. In Chile, CEC Salud UC asks for coverage through formal closure, including the last follow-up; the other Chilean committee rules we read don’t set a term.
Who must hold the policy, the sponsor or the CRO?
The sponsor, or the authorization holder in Chile. According to ClinRegs, Peru accepts a policy held by the sponsor or the CRO, but under art. 29 the sponsor’s duty to compensate stays in place. Costa Rica also requires the sponsor to cover the investigator and team, and the PI to hold their own policy.
Does Mexico still require the policy before approval?
COFEPRIS no longer requires it in the initial application, since its April 2025 simplification Acuerdo. The policy or fund is filed within 15 business days after protocol authorization, and missing it can lead to revocation. Ethics committees may still ask to see it before they approve.
Are medical-device trials treated the same as drug trials?
Mostly, but through different rules. Argentina’s 2025 rule and Colombia’s GCP resolution are written for medicines. Guatemala’s Acuerdo 82-2019 covers device trials too (§§2, 41, 43.8). In Argentina, ANMAT’s device rule has no insurance clause, but Buenos Aires City law requires insurance or another financial guarantee for research there, and Buenos Aires Province requires the health institution to show insurance before a higher-risk protocol is approved. Colombia’s INVIMA checks for a policy in device studies under Res. 8430/1993. Chile’s statute covers devices, with the classes still to be set by a decree that hasn’t been issued, and DS 114/2010 art. 25 requires every protocol to set out its insurance and guarantees; in the meantime, Chilean ethics committees such as Universidad de Chile’s CEISH and Hospital del Trabajador’s CEC already ask for the policy in device or implant trials. Córdoba’s ethics council requires it for non-registration pilot studies of devices. Costa Rica’s Ley 9234 requires the policy for clinical research, defined as experimental, clinical or interventional biomedical research (arts. 2 and 31), whatever the product, so device trials are included. Peru’s DS 021-2017-SA defines the investigational product as a pharmaceutical product or a medical device (art. 2), so its art. 28 insurance rule applies to device trials too.
Sources
Primary texts were read on 28 October 2026 and re-checked, with the insurance laws added, on 29 October 2026. See the inline links above and in the table. Ethics-committee documents (CONEP; Córdoba’s CoEIS; La Sabana and Valle del Lili in Colombia; EsSalud Cusco in Peru; and seven Chilean committees) were read on 29 October 2026 and are linked where cited; they describe committee practice, not law. Secondary, and labelled where used: NIH ClinRegs country profile for Mexico.
Last verified: 29 October 2026. Written by Julio G. Martinez-Clark, CEO of bioaccess®.