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:
- Guatemala: Acuerdo Ministerial 82-2019 §§10–11 require insurance covering all resulting damage before the trial starts. The Acuerdo covers drug and device trials alike (§§2 and 41), and a copy of the trial policy is part of the device-trial application (§43.8). The insurer must be established in Guatemala or working with a Guatemalan insurer, and payouts must equal what the sponsor would pay for the same damage in the trial’s country of origin (§11.3).
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 Guatemala clinical trial coverage, buy trial insurance Guatemala device FIH, Guatemala trial liability, 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 We do not quote a binder.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.
Guatemala is one of the countries where bioaccess® runs studies. Confirm current ethics and coverage rules with qualified advisers. bioaccess® is not the carrier.
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: Guatemala 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-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.
What Guatemala’s rule does and doesn’t set
See Clinical Trials in Guatemala. This page exists so “buy Guatemala trial coverage” does not treat the CRO as the underwriter. Acuerdo Ministerial 82-2019 sets the rule (insurance in place before the trial starts, for drug and device trials) but no minimum amount. Typical ethics asks still apply: territory, period, additional insureds, language.
What ethics committees and the national authority actually ask for
Use the live Guatemala country page.
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 excludes Guatemala fails the packet. A Guatemala-only local policy that cannot add Panama later is a protocol constraint. bioaccess® runs first-in-human studies in Colombia now.
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. Guatemala is on the public countries hub. We pick the country the device needs.
- 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
Public line: bioaccess® runs first-in-human studies in Colombia now — local entity, Miami headquarters, own CRO in Colombia. Colombia’s regulatory framework is changing for the better. INVIMA commercial registration remains. 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 covers the Guatemala 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 Guatemala clinical trial coverage, start as the operator: contact bioaccess® or book from First-in-Human CRO. Guatemala operator: Clinical Trials in Guatemala. Hub: Clinical Trial Liability Insurance in Latin America: Requirements by Country.
Julio G. Martinez-Clark, CEO · bioaccess®