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. The rule for this country, from the primary text:
- 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.
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 its regulating Decreto 12.651/2025. Art. 39 of that 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.
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 Brazil ANVISA clinical trial liability, CONEP trial insurance, buy clinical trial coverage Brazil device, 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.
Brazil is a real device-trial geography. It is also a documentation geography. In Brazil the sponsor owes indemnity whether or not a policy exists (Lei 14.874/2024, arts. 23 and 26 XV). bioaccess® prepares the ethics and ANVISA file. If a policy is bought, a carrier writes the liability 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: ANVISA / CONEP / CEP insurance exhibit. 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 and ANVISA 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.
ANVISA is the device dossier. Indemnity is in the ethics stack
Device investigations sit under RDC 837/2023 (Portuguese dossier: IB, protocol, ICF and GMP evidence). On insurance, what CEPs check is that the consent form states the right to indemnity without tying it to a policy (CONEP manual, 2015).
Portuguese, period, and named insureds
CEP/CONEP review the consent form’s indemnity wording, not a policy. If a site contract or the sponsor’s own program requires a policy, a Portuguese translation helps the site and any local insurer, the period should run past last-patient last-visit, and the form should name the site as well as the sponsor.
What ethics and ANVISA actually ask for
Use Clinical Trials in Brazil. A CEP reviews ethics under Lei 14.874/2024 and ANVISA reviews device trials under RDC 837/2023. Trial authorization and later market registration are separate workstreams.
CEPs and CONEP don’t ask for proof of insurance (CONEP manual, 2015). If a site contract or another reviewer asks for a policy, 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. CONEP says indemnity can’t be capped at the amount insured. Ask the carrier and the CRO together, before the packet goes in.
Local policy vs controlled master
Under Lei 14.874/2024 the sponsor must indemnify participants; the law does not itself require a policy. Lei Complementar 126/2007, art. 19, requires cover for risks in Brazil bought by persons domiciled in Brazil to be placed in Brazil, with exceptions in art. 20. Whether that reaches your structure (for example, a foreign sponsor buying abroad) is a question for a SUSEP-licensed broker. Whatever you buy, the consent form reviewed by CEP/CONEP must not tie indemnity to it. A master that excludes Brazil, or a local policy that cannot later add Colombia, is a protocol constraint — tell the CRO before you freeze the country list.
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. If Brazil is the wrong first country for this device, say so early. bioaccess® still runs trials in Colombia and other Latin American countries. Insurance territory is not a reason to pretend Brazil is Panama.
- Protocol, IB, ICF, and the ethics and ANVISA 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. In Panama and Colombia alike, ethics timing depends 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 covers the ANVISA / CONEP / CEP insurance exhibit.
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 Brazil ANVISA clinical trial liability, start as the operator: contact bioaccess® or book from First-in-Human CRO. Brazil operator page: Clinical Trials in Brazil. Hub guide: Clinical Trial Liability Insurance in Latin America: Requirements by Country.
Julio G. Martinez-Clark, CEO · bioaccess®