General information, not insurance, legal, or regulatory advice. Confirm current ethics-committee, regulatory, import and coverage rules with qualified advisers and a licensed broker. This page does not quote premiums, limits or carrier rates.
What the law says (verified 29 October 2026)
Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country sets out each country’s rule with links to the primary text. Recent rule changes and the primary-law rules that matter most for this topic:
- Mexico: under the COFEPRIS simplification Acuerdo of 24 April 2025 (DOF 28 April 2025), art. 5, the study insurance (policy or certificate) or a current financial fund is no longer part of the initial COFEPRIS application. It must be filed within 15 business days after the protocol is authorized, or the authorization can be revoked. This changed only the COFEPRIS filing: ethics committees may still ask to see the policy before they approve. No-risk observational studies are exempt. NOM-012-SSA3-2012 §5.14 still requires the fund for compensation. See Mexico’s 15-business-day rule.
- Argentina: ANMAT Disposición 7516/2025 (in force 1 December 2025, replacing Disp. 6677/2010), Annex II §3.14, says a study may start only once the sponsor has contracted a “seguro constituido en el país” (insurance taken out in Argentina). The consent form must name the insurer and its address. This applies to clinical pharmacology studies of medicines. ANMAT’s device rule (Disp. 969/1997) has no insurance clause, but Buenos Aires City law requires insurance or another financial guarantee for research there (Ley 3301, art. 12), and Buenos Aires Province requires the health institution to show insurance before a higher-risk protocol is approved (Decreto 3389/2024, art. 8).
- Panama: Decreto Ejecutivo 21 of 23 April 2026, art. 67(2), requires the investigator to obtain from the sponsor “financial provisions” for compensating possible damage and to attach that agreement to the bioethics submission. We did not find an explicit insurance-policy mandate in the decree; a certificate of insurance is the usual way to document the provision, and committees may ask for one.
- Brazil: Lei 14.874/2024 (arts. 23 and 26 XV) makes the sponsor responsible for indemnifying participants and for their trial-related care. The statute itself does not require an insurance policy, and its regulating Decreto 12.651/2025 adds none that we found. CEPs and CONEP don’t ask for proof of insurance (CONEP manual, 2015). Under Lei Complementar 126/2007, art. 19, insurance bought by Brazil-resident people or Brazil-domiciled companies for risks in Brazil must be placed in Brazil, with narrow exceptions in art. 20.
- Peru: DS 021-2017-SA, art. 28, requires a policy with coverage in Peru (a foreign insurer needs a legal representative in Peru), a financial fund for immediate care until the policy pays, the policy details in the consent form, and validity until the National Final Report, renewed while late damage is possible.
- Costa Rica: Ley 9234 art. 31 and Decreto 39061-S art. 14 require a civil liability policy enforceable in Costa Rica, from an insurer with a branch or service center in the country. Under the decree it runs at least two years after the final report is delivered to the ethics committee (art. 14(a)) and three years after each participant’s participation ends (art. 14(b)); Ley 9234 art. 31 sets a floor of two years after participation ends. Each participant receives proof of the policy (art. 32). See Costa Rica under Ley 9234.
None of these rules sets a minimum dollar limit. Limits come from contracts and underwriting. Insurers price a specific protocol, so see what insurers need before they’ll quote.
If you searched named insured site vs sponsor clinical trial, additional insured PI ethics committee, certificate of insurance named insured FIH, you were looking for someone who would write international clinical-trial coverage for an investigational device. bioaccess® is a first-in-human medical-device CRO. We are not an insurance carrier. We do not underwrite policies. We do not sell premiums. We do not quote a binder. OUS and Latin American device trials still need trial-specific liability — local admitted paper, a master with local certificates, or both. We run the trial under ISO 14155. We can introduce a specialty carrier. That introduction is not a signed partnership on this page, and it is not a quote.
Ethics often wants the site and the PI on the certificate, not only the Delaware HoldCo. Sponsors hear “named insured” and add the wrong legal entity. This is not site-policy versus sponsor-policy (separate page). That page is whose form. This page is whose name is on the form.
This page is separate from Clinical Trial Liability Insurance in Latin America: Requirements by Country. That hub sets out each country’s legal requirement with primary-law citations. This page’s topic: who must appear as named/additional insured. Same operator: the CRO runs the trial; a carrier writes the paper.
The CRO is not the carrier
Founders type “buy clinical trial insurance” and land on CROs, brokers, and hospital MSAs in the same result set. Those are three jobs:
- Carrier. Underwrites participant injury, medical expenses for trial-related events, defense, and site/investigator indemnification — if the form matches the protocol. A hallway conversation is not a binder.
- Broker. Places the form, translations, additional-insured endorsements, and territory wording. Licensed where the paper has to sit.
- CRO. Protocol, IB, ICF, ethics-committee and national authority submission, importer of record for clinical trial devices in Latin America, ISO 14155 monitoring, SAE clock, TMF, and the 21 CFR 812.28 narrative. See OUS FIH and FDA IDE. Eligibility of foreign data is not FDA clearance.
Mixing those jobs is how a startup buys a U.S. product-liability rider, emails a PDF to an ethics committee, and gets a resubmission. Product liability is not clinical-trial liability. A site’s institutional policy is not the sponsor’s trial form.
Sponsor is the insured. Site is often additional insured
The sponsor buys the trial-liability form because the protocol is the sponsor’s. The committee still may require the institution and the investigator as additional insureds so a claim does not bounce between MSA indemnity and a policy that never named them. Endorsements take calendar time. Start them with protocol development, not the week of the CEC meeting.
Wrong entity, wrong country, wrong period
Naming a US parent when the CTA is with a subsidiary, naming a hospital system when the site is a foundation, or naming last year’s PI, are classic resubmissions. Spanish (or, for a Brazilian site that asks for one, Portuguese) certificates must match the legal names in the ethics packet. Confirm with the reviewing body and the broker. bioaccess® coordinates the packet. We do not issue endorsements.
What ethics committees and the national authority actually ask for
Use Clinical Trials in Panama. Panama’s Ministry of Health (MINSA), through the Dirección Nacional de Farmacia y Drogas, is the national file. Ethics review runs through institutional bioethics committees registered with the Comité Nacional de Bioética de la Investigación (CNBI). Published ethics typically 3–5 weeks; with bioaccess® coordination, protocol submission to first-patient enrollment averages 6–8 weeks on that hub. Per-patient costs there: $12,000–$22,000 in U.S. dollars. A hallway conversation at this hospital is not MINSA clearance. Use Clinical Trials in Peru. INS (under DS 021-2017-SA) authorizes trials. A published statutory target on that hub is 40 business days in the drug-trial framework, and 60 business days when a biologics / technical commission applies. A novel first-in-human device may take longer. DIGEMID under MINSA regulates devices and investigational import. Accredited ethics is required. The Peru country page cites experience-based costs about ~30% lower than in the US.
Insurance documentation is usually in the ethics-committee and national authority submission, not a post-approval formality. Two exceptions: in Mexico the policy goes to COFEPRIS within 15 business days after authorization, and in Brazil CEP/CONEP don’t ask for proof of insurance. Typical asks (confirm with the reviewing body):
- Territory that names every country on the protocol.
- Site and principal investigator as additional insureds when the committee requires it.
- Policy period through last-patient last-visit plus the protocol follow-up window.
- Spanish (or Portuguese) certificate or notarized summary when the committee asks for it.
- Claims-notice language that can sit next to the SAE clock, not against it.
None of the national rules or ethics-committee documents we read sets a per-participant dollar minimum. Ask the carrier and the CRO together, before the packet goes in.
Local policy vs controlled master
A master that cannot add additional insureds in-country is the wrong master. A local policy that names only the site and not the sponsor is also the wrong object. Ask for a specimen showing both before you bind.
A “controlled master” that never issues a local certificate is a slide, not a submission. A local-only policy that cannot travel to a second Latin American country is a one-country trap. The operator chooses geography for the device; the paper has to follow the protocol, not the other way around.
What bioaccess® still owns after you have a quote
- Regulatory-fit, not tourism. Site-page campuses are names on a certificate, not sellers of one. Do not email Favaloro or a Recife hospital to “be the insured” instead of buying sponsor paper.
- Protocol, IB, ICF, and the ethics-committee and national authority submission with insurance documents in the same stack — not a parallel founder email.
- Importer of record and device accountability. A binder does not import the investigational product.
- Site activation: contracts, training, investigational product, EDC, monitoring plan. A site MSA that “includes insurance” is still not ISO 14155 monitoring.
- Introducing a specialty carrier when the founder does not already have admitted paper. An introduction is not a partnership or a quote.
The firm was founded in 2010. Published first-in-human device case studies show FIH execution with import and insurance as workstreams — not as bioaccess® underwriting.
Colombia is still on the map
A site-name search sometimes arrives with a stale story that bioaccess® “left Colombia.” That is false. bioaccess® runs first-in-human studies in Colombia now. bioaccess® has a local entity and office in Colombia, with headquarters in Miami. Ethics review in both Panama and Colombia runs on each committee’s meeting schedule. The country page’s published per-patient comparison: $12K–$22K vs. $15K–$25K as published on Clinical Trials in Panama. We pick the country the device needs. The founder podcast is Global Trial Accelerators™.
A Bogotá or Floridablanca ethics packet still wants financial responsibility for participant injury. bioaccess® still runs clinical trials in Colombia. We pick the country the device needs.
Frequently asked questions
Does bioaccess® sell clinical trial insurance?
No. We are the FIH CRO. We can introduce a carrier. We do not underwrite. We do not bind.
Is this the same article as the LATAM insurance hub?
No. The hub is Clinical Trial Liability Insurance in Latin America: Requirements by Country. This page is who must appear as named/additional insured.
Can a U.S. product-liability policy cover a LATAM device FIH?
Only if the territory clause and the trial-liability form actually name the countries and the investigational activity. Many U.S. GL/PL policies exclude OUS research. Get it in writing from the carrier. A verbal “we’re global” is not an ethics exhibit.
Next step
If the search that brought you here was named insured site vs sponsor on the FIH certificate, start as the operator: contact bioaccess® or book from First-in-Human CRO. Related pages: site vs sponsor policy, investigator vs sponsor.
Julio G. Martinez-Clark, CEO · bioaccess®